Optomed HALO User Manual

Automated Portable Retinal Camera
User Manual
Reading through accompanying documents is a mandatory
action before using this equipment
810-C2701-131
Rev. D
Automated Portable Retinal Camera (Optomed HALO)
User Manual
Content
1 Introduction
1.1
Outline
1.2
Intended use
1.3
Indication for Use
1.4
Proper instrument use
2 Safety information
2.1
Displays for safety use
2.2
Symbols and labels
2.3
Protective packing symbols
2.4
Product labels
2.5
Service life
2.6
Cybersecurity information
2.7
Cybersecurity functions
2.8
Data back up
3 Instrument description
3.1
Introduction
3.2
Standard accessories
4 Log in and introduction of user interface
4.1
Patient management
4.2
Capture image
5 Specifications
5.1
Product specification
5.2
Environmental conditions
5.3
Electric rating
6 Maintenance
6.1
Lens cleaning
6.2
Chinrest and forehead rest
7 Software installation
8 Installation and setup with external laptop
8.1
Place carton box on the floor.
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8.2
8.3
8.4
8.5
8.6
Remove the buckles
Take off the Optomed Halo machine
Setup machine and relative cables
Connect the external laptop
Remove lens cover
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1 Introduction
1.1 Outline
The Automated Portable Retinal Camera Optomed Halo is an auto
3D tracking, fast and easy to carry retinal imaging system. Optomed Halo
is designed to provide images of the eye as an aid to clinicians in the
diagnosis of diabetic retinopathy, AMD, glaucoma and other retinal
diseases.
1.2 Intended use
Optomed Halo provides non-mydriatic color retina and external
images of the eye as an aid to clinicians in the evaluation and diagnosis
of eye disease.
1.3 Indication for Use
Optomed Halo is a non-contact, high resolution digital imaging device
which is suitable for photographing, displaying and storing images of the
retina and external areas of the eye to be evaluated under non-mydriatic
conditions.
Optomed Halo is indicated for in-vivo viewing of the posterior and
external area of the eye and the images are intended for use as an aid to
clinicians in the evaluation, diagnosis and documentation of ocular
health.
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1.4 Proper instrument use
1. Optomed Halo is a medical device; it must be operated by properly
trained and qualified person(s) only. The operation should be
supervised by a physician. If abnormal behavior is observed due to EM
disturbances, please relocate the device accordingly.
2. Please be sure to read the user manual to understand the safety
precautions before operating this device.
3. Always enter patient information first.
4. Prepare patient contact surfaces (forehead and chin rest) according to
the cleaning method in this manual.
5. Instantly turn off the power switch of this instrument and disconnect
the power cable if uncertain problems arise.
6. Clean ocular lens frequently to ensure good image quality.
7. Adjust the height of motorized adjustable table properly to ensure
patient’s comfort during the examination.
8. Align the patient’s eye position to the canthus indicator mark on the
chin and forehead rest assembly.
9. Dim the room lights to allow natural dilation of the patient’s pupil and to
provide a comfortable visualization of the fixation target without glare.
10. Inspection of the system’s functionality before use whether any repair
is needed.
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2 Safety information
2.1 Displays for safety use
Display
Meaning
WARNING
CAUTION
“WARNING” indicates the presence of a hazard
that could result in severe personal injury.
“CAUTION” indicates the presence of a hazard
that could result in minor injury.
“NOTE” provides useful information for
operation which is important.
NOTE
WARNING
Accessory equipment connected to the digital
interfaces must be certified according to the
respective IEC standards (e.g., IEC 60950 for
laptop or IEC 60601-1 for medical equipment).
Furthermore, all configurations shall comply
with the system standard IEC 60601-1-1 and
IEC 60601-1:2005. Any person who connects or
installs devices to the system has responsibility
to verify that compliance. If in doubt, consult the
Optomed local representative or distributor.
WARNING
WARNING
WARNING
To avoid risk of electric shock, this equipment
must only be connected to the supply mains
with protective earth.
Do not modify this equipment without
authorization of the manufacturer.
THE Optomed Halo CANNOT REPLACE
CLINICAL JUDGEMENT AND IS INTENDED
TO BE USED ONLY IN CONJUCTION WITH
OTHER CLINICAL TOOLS CONSIDERED TO
BE THE STANDARD OF CARE FOR
MEASUREMENT AND DIAGNOSIS OF THE
EYE.
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WARNING
The Optomed Halo is a medical device. The
software and hardware has been designed in
accordance with U.S., European and other
international medical device design and
manufacturing standards. Unauthorized
modification of the Optomed Halo software or
hardware, or any addition or deletion of any
application in any way can jeopardize the safety
of operators and patients, the performance of
the instrument, and the integrity of patient data.
Any changes, additions or deletions to
factory installed applications, operating
system or modifications to hardware in any
manner VOIDS the Warranty completely.
WARNING
Optomed Halo is not intended for home use and
may not be stored or operated in environment
conditions other than those prescribed. (see
Specification)
WARNING
Phototoxicity
Because prolonged intense light exposure can
damage the retina, the use of the device for
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.
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WARNING
Do not obstruct the mains power switch or
position the equipment where the connection to
the mains line can be accidentally
disconnected.
WARNING
Equipment is not suitable for use in the
presence of a Flammable Anesthetic Mixture
with Air, Oxygen, or Nitrous Oxide.
WARNING
The Optomed Halo has no special protection
against harmful ingress of water or other liquids
(classified IPX0). To avoid damage to the
instrument and cause a safety hazard, the
cleaning solutions, including water, should not
be directly applied to the device. Using a
dampened cloth (without dripping), is a good
method to clean the exterior surface of the
enclosure.
WARNING
The patient cannot touch any electrical device
that is not powered by Optomed Halo with any
part of his or her body while being examined. In
addition, the Optomed Halo operator must not
attempt to touch the patient and any electrical
device that is not powered by Optomed Halo at
the same time while examining the patient.
Failure to do so could result in electrical shock
to the patient and/or operator.
WARNING
Do not connect the instrument with anything
other than specified. Otherwise, it may result in
fire or electric shock. For details of purchasing
accessories, please contact a Optomed
representative or distributor.
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CAUTION
Be sure to hold the bottom of the base when
Optomed Halo is moved.
CAUTION
CAUTION
When adjusting chinrest, be careful not to pinch
the patient’s hand.
The device need to install on the stable table.
Do not install in location that are unstable or
exposed to vibration
CAUTION
Federal law restricts this device to sale by or on
the order of a Physician or Practitioner (CFR
801.109(b)(1)).
CAUTION
Careful consideration of this information is
essential when stacking or collocating
equipment and when routing cables and
accessories.
CAUTION
Please do not use any other cables or
accessories not approved by the manufacturer
in this manual to avoid negative influence on
electromagnetic compatibility.
CAUTION
This equipment is not intended for use in
residential environments and may not provide
adequate protection to radio reception in such
environments.
CAUTION
Distance between Optomed Halo and wall not
less than 22cm
CAUTION
To ensure cleanliness, replace the chinrest
paper whenever changing patients.
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2.2 Symbols and labels
Presence of electrical shock hazard.
Note: Indicates risk of electrical shock due to the
presence of uninsulated high voltage inside the
instrument.
Do not remove the instrument cover or parts.
Circuit Breaker
Type B applied parts.
Note: This instrument complies with the specified
requirements to provide protection against electrical
shock, particularly regarding allowable patient leakage
current.
Manufacturer
Crystalvue Medical Corporation
No. 116, Ln. 956, Zhongshan Rd., Taoyuan Dist.,
Taoyuan City 33072, Taiwan
Authorized Representative in the European Union
Medical Device Safety Service (MDSS) GmbH
Schiffgraben 41
30175 Hannover, Germany
Serial number
Catalog number / part number
Prescription Use
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2.3 Protective packing symbols
The protective packing symbols specify the handling requirements and
the transport and storage conditions.
Fragile, Handle with care
Keep dry
This end up
Relative Humidity
Temperature
Do not stack
2 Layers only
Waste Electrical and Electronic Equipment (WEEE)
Recycling Instructions
When determined that the device is ready for disposal, it is to
be recycled following the policies and procedures reflecting
respective country’s requirements.
Do not dispose of
device as general waste.
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Product compliance
93/42/EEC/M5 Medical Device Directive
Indicates this equipment contains Type B applied parts
The Optomed Halo is classified as follows:
Class I Equipment – Protection against electrical shock.
Type B – Degree of protection against electric shock of
applied part (chin and forehead rests).
Ordinary Equipment (IPX0) – Degree of protection against
ingress of liquids (none) (4th edition).
Continuous Operation – Mode of operation
Electromagnetic Compatibility (EMC):
EN 60601-1-2:2015 (4th edition)
The Optomed Halo TM device has been tested to comply
with the emission and Immunity requirements of
EN60601-1-2:2015 (4th edition).
The Optomed Halo TM is
intended for use in an electromagnetic environment where
radiated RF disturbances are not beyond the standard
defined in EN60601-1-2:2015 (4th edition).
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Certification: under IEC 60601-1
Guidance and manufacturer’s declaration – electromagnetic emissions
The Optomed Halo is intended for use in the electromagnetic environment specified below. The
customer or the user of the Optomed Halo should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
Group 1
The Optomed Halo uses RF energy only for its
internal function. Therefore, its RF emissions are very
CISPR 11
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
Class A
establishments other than domestic and those
CISPR 11
Harmonic emissions
Class A
flicker emissions
IEC 61000-3-3
directly connected to the public low-voltage power
supply network that supplies buildings used for
IEC 61000-3-2
Voltage fluctuations/
The Optomed Halo is suitable for use in all
Complies
domestic purposes.
WARNING: The Optomed Halo is intended for
use by healthcare professionals only.
The Optomed Halo may cause radio
interference or may disrupt the operation of
nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or
relocating the system, or shielding the location.
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Manufacturer’s declaration-electromagnetic immunity
The Optomed Halo is intended for use in the electromagnetic environment (for professional healthcare) specified
below.
The customer or the user of the Optomed Halo should assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance level
Electromagnetic
environment-guidance
(for professional healthcare
environment)
test level
Electrostatic
Contact:±8 kV
Contact:±8 kV
Floors should be wood, concrete or
discharge(ESD)
Air±2 kV,±4 kV,±8 kV,
Air±2 kV,±4 kV,±8
ceramic tile. If floors are covered
IEC 61000-4-2
±15 kV
kV,±15 kV
with synthetic material, the relative
humidity should be at least 30%
Electrical fast
+ 2kV for power supply
+ 2kV for power supply
Mains power quality should be that
transient/burst
lines
lines
of a typical professional healthcare
IEC 61000-4-4
+ 1kV for input/output
Not applicable
environment.
lines
Surge
+ 0.5kV, +1kV line(s) to
+ 0.5kV, +1kV line(s) to
Mains power quality should be that
IEC 61000-4-5
line(s)
line(s)
of a typical professional healthcare
+ 0.5kV, +1kV,+ 2kV
+ 0.5kV, +1kV,+ 2kV
environment.
line(s) to earth
line(s) to earth
Voltage Dips, short
Voltage dips:
Voltage dips:
Mains power quality should be that
interruptions and
0 % UT; 0,5 cycle
0 % UT; 0,5 cycle
of a typical professional healthcare
voltage variations on
0 % UT; 1 cycle|
0 % UT; 1 cycle
environment. If the user of the
power supply input
70 % UT; 25/30 cycles
70 % UT; 25 cycles
Optomed Halo requires continued
lines
IEC 61000-4-11
operation during power mains
Voltage interruptions:
Voltage interruptions:
interruptions, it is recommended that
0 % UT; 250/300 cycle
0 % UT; 250 cycles
the Optomed Halo be powered from
an uninterruptible power supply or a
battery.
Power frequency(50,
30 A/m
30 A/m
The Optomed Halo power frequency
60 Hz) magnetic field
50 Hz or 60 Hz
50 Hz
magnetic fields should be at levels
IEC 61000-4-8
characteristic of a typical location in
a typical professional healthcare
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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Manufacturer’s declaration-electromagnetic immunity
The Optomed Halo is intended for use in the electromagnetic environment (for professional healthcare) specified below.
The customer or the user of the Optomed Halo should assure that it is used in such and environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment-guidance
(for professional healthcare environment)
Conducted RF
3 Vrms:
3 Vrms:
Portable and mobile RF communications
IEC 61000-4-6
0,15 MHz – 80 MHz
0,15 MHz – 80 MHz
equipment should be used no closer to any part of
6 Vrms:
6 Vrms:
the Optomed Halo including cables, than the
in ISM bands between
in ISM bands between
recommended separation distance calculated from the
0,15 MHz and 80 MHz
0,15 MHz and 80 MHz
equation applicable to the frequency of the transmitter.
80 % AM at 1 kHz
80 % AM at 1 kHz
Recommended separation distance:
Radiated RF
3 V/m
3 V/m
d = 1,2 √P
IEC 61000-4-3
80 MHz – 2,7 GHz
80 MHz – 2,7 GHz
d = 1,2 √P
80MHz to 800 MHz
d = 2,3 √P
800MHz to 2,7 GHz
80 % AM at 1 kHz
80 % AM at 1 kHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
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Recommended separation distance between
portable and mobile RF communications equipment and the Optomed Halo
The Optomed Halo is intended for use in an electromagnetic environment (for professional healthcare) in which radiated RF
disturbances are controlled. The customer or the user of the Optomed Halo can help prevent electromagnetic interference by
maintaining a minimum and wall portable and mobile RF communications equipment (transmitters) and the Optomed Halo as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
Separation distance according to frequency of transmitter
of transmitter
m
W
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,7 GHz
d =1,2√P
d =1,2√P
d =2,3√P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
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 output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
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Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The Optomed Halo is intended for use in the electromagnetic environment (for professional healthcare) specified below.
The customer or the user of the Optomed Halo should assure that it is used in such an environment.
Modulation b)
Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance LEVEL
(V/m)
(for professional
healthcare)
Pulse
modulation b)
18 Hz
1,8
0,3
27
27
0,3
28
28
0,2
0,3
9
9
GSM 800/900,
TETRA 800,
Pulse
800 – 960 iDEN 820,
modulation b)
CDMA 850,
18 Hz
LTE Band 5
2
0,3
28
28
1 700 –
1 990
GSM 1800;
CDMA 1900;
Pulse
GSM 1900;
modulation b)
DECT;
217 Hz
LTE Band 1, 3,
4, 25; UMTS
2
0,3
28
28
2 400 –
2 570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2
0,3
28
28
5 100 –
5 800
Pulse
WLAN 802.11
modulation b)
a/n
217 Hz
0,2
0,3
9
9
Test frequency
(MHz)
Band a)
(MHz)
385
380 –390 TETRA 400
450
430 – 470
GMRS 460,
FRS 460
704 – 787
Pulse
LTE Band 13,
modulation b)
17
217 Hz
710
745
780
810
870
930
1 720
1 845
1 970
2 450
5 240
5 500
5 785
Service a)
FM c)
±5 kHz deviation 2
1 kHz sine
Pulse
modulation b)
217 Hz
NOTE
If necessary to achieve the IMMUNITY TEST LEVEL , the distance between the transmitting antenna and the ME
EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a)
b)
c)
For some services, only the uplink frequencies are included.
The carrier shall be modulated using a 50 % duty cycle square wave signal.
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent
actual modulation, it would be worst case.
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2.4 Product labels
Optomed Halo system labels (samples only):
2.5 Service life
The service life of Optomed Halo is five years if specified inspections
and maintenance are done.
2.6 Cybersecurity information
2.6.1 Objective
The purpose of this section is to summarize the cybersecurity
controls of the Optomed Halo system.
2.6.2 System overview
The Optomed Halo system has the following interface that are
critical for cybersecurity:
• USB ports of the laptop or PC for connecting to various USB
devices.
2.6.3 General principles
• Cybersecurity risk management is a shared responsibility
among stakeholders including the medical device
manufacturer, the user, and the health care facility. Failure to
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maintain cybersecurity can result in compromised device
functionality, loss of data availability or integrity, or expose
other connected devices or networks to security threats.
• The laptop or PC is limited to install Windows 10 operation
system and is dedicated for Optomed Halo, for the risk of
viruses and other malwares, users must install and enable
window defender or anti-virus software and follow the
suggestion of third- party software (including virus updates) to
update it.
2.7 Cybersecurity functions
2.7.1 Authentication of users
Optomed Halo system uses Microsoft Windows 10 as the main
operating system. The operating system itself allows the end
user to establish and configure “User Accounts” (example:
standard users, power users, administrators) and “User
Passwords” so that authentication is performed by password.
2.7.2 Auto-logoff
• The operating system has the ability to prevent access and
misuse by unauthorized users if the device is left idle for a
period of time.
• The length of inactivity time before auto-logoff/screen lock is
user/administrator configurable.
• The auto-logoff/screen lock should be always enabled.
• Local supervisor should avoid unauthorized users access the
delicate Laptop or PC in order to preserve system and data
confidentiality, integrity and availability.
• Local supervisor must set the expiration time of screen saver
to reduce casual viewing data.
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2.8 Data back up
• To avoid the loss of patient data due to damage to the storage
device of the user's PC, it is recommended that the user
should regularly back up the data.
• It is recommended to store the data in multiple different and
independent storage media to disperse the risk of data loss or
damage to the storage device.
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3 Instrument description
3.1 Introduction
OM
Forehead rest
Ocular lens
Power switch
(Back side)
(
Base
Chinrest
(motorized)
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D-Sub I/O
AC power in
D-Sub I/O
Power switch
USB to external laptop
or tablet or PC
3.2 Standard accessories
Item
Description
Q’ty
1
User manual
1 pc.
2
USB cable
1 pc.
3
AC power cord
1 pc.
4
D-Sub cable
1 pc.
5
Dust cover
1 pc.
6
Lens cover
1 pc.
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4
Log in and introduction of user interface
◼ Log in
Username
Password
⚫
Username: Input the user name.
⚫
Password: Input the password.
◼
Default account:
⚫
Username: camera
⚫
Password: 00000000
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◼ Modify account
After logging in, go to the settings page to modify the username and password.
Username
Password
Confirm
Password
Account
⚫
Username: Change username when needed.
⚫
Password: Change password when needed.
⚫
Confirm password: Confirm the password.
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If the password inputs are not same, please check them again.
If the password inputs are same, below dialog is displayed.
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◼ Change password every six months
Password is requested to be changed every six months.
⚫
Old password: Input the old password.
⚫
New password: Input the new password.
⚫
Confirm new password: Input the password again.
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Below graph shows error occurs.
Click Change button if no error occurs.
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Below error message means input password is incorrect.
Below graph shows new password is changed successfully.
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Three tabs are displayed on screen after logging in and describe in below
sections.
Patient management
Capture Image
Review captured image
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4.1 Patient management
Select patient, add patient and modify patient information
Search
Information
Quick Search
Delete / Edit
Settings
Patient List
Add
Pati
ent
Recent Images
◼
Patient list: Displays all the patients associated with the search result.
◼
Search: Provide patient search function by entering keywords.
⚫
◼
Search by all fields: Fill in keyword such as “Moon”
Add patient
: Click to add new patient profile and information.
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⚫
The columns with * mark are mandatory before adding new patient
to database.
⚫
By clicking
, the new patient information is saved to the database.
The main screen will then return to the main Patient Information
window and the newly added patient is listed under the patient list
window. Select the new patient added and patient detail will be
displayed accordingly.
⚫
◼
By clicking
, it will return to main patient window without saving.
Patient information
Displaying selected patient information
⚫
Edit patient information
：Click for patient information editing and
comment editing saving. The operations are just like Add Patient.
⚫
Delete patient
： Click for delete patient information and images.
When the “Delete” dialog appears, click “OK” to delete patient
information or click “Cancel” to quit.
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⚫
Settings
⚫
Packing: Enabling auto packing, the camera head moves to packing
: Click to show settings of Optomed Halo program
position before Optomed Halo shutting down.
⚫
Export: Enabling auto export, the captured image will be copied to
specific path automatically where the user set
⚫
Archive: Creates a backup file of Optomed Halo database.
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Step1. Choose the target folder for backup file
Step2. Click “ARCHIVE” button to create backup file
The target folder for backup file
Process progress
NOTE: The file system of target drive should be NTFS
⚫
Restore: Restore the database of Optomed Halo by backup file
Step1. Choose the target folder where the backup file is saved
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Step2. Choose the backup file from the list and click the “RESTORE”
button to restore the database of Optomed Halo
Backup file list
⚫
Language: Multi-language selection
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Automated Portable Retinal Camera (Optomed HALO)
User Manual
⚫
About: Display software version of Optomed Halo
4.2 Capture image
Main window for image capture
X/Y Control
Patient Name or Patient ID
Capture Mode Control
Chinrest
Lighting Control
Fixation
Setting
Diopter Control
OS/OD
Select
Start
Capture
Z Control
Mode
Selection
Default
Position
Advance
Setting
Control buttons on the screen
◼
Chinrest: Control chinrest up and down
◼
Z Control: Move camera forward or backward
◼
X/Y Control: Click center of pupil on screen to alignment
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User Manual
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Reset: Reset camera to default position
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Fixation setting: Selection of the fixation position
◼
OS/OD select: Choose OD or OS for image capture
◼
Start: Click for automatic eye alignment and image capture
◼
Mode selection: Auto alignment mode or manual alignment mode
◼
Advanced: Display settings of Optomed Halo program
⚫
Semi auto mode: User needs to switch eye manually.
⚫
Full auto mode: The Optomed Halo will switch to another eye
automatically.
⚫
Enable manual mode helper: It can help to find suitable working
distance and do capture processes automatically if enable it.
◼
Capture mode control: Display capture mode setting panel and provide
retina (default) and cornea mode.
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User Manual
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Diopter control: Display diopter setting panel and provide empty lens
(default), - lens and + lens
◼
Lighting control: Display lighting setting panel and provides viewing and
flash LED level
◼
Dilate selection: The captured image will save with this setting.
4.2.1 Automatic alignment and focus operation
◼
Adjust chinrest with
◼
Click pupil position on screen to align the camera.
◼
Click
and table to suitable position.
to start tracking and capture.
4.2.2 Montage mode
◼
Press and hold the Start button for 3 seconds, the Montage button will
be shown.
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User Manual
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Click the montage button and select fixation LEDs.
◼
Click the SET button.
◼
Click the OK to start montage capture
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Automated Portable Retinal Camera (Optomed HALO)
User Manual
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Click CONTINUE button for next shot.
4.2.3 Manual alignment and manual capture
◼
Click mode selection button to manual mode
◼
Adjust chinrest by
◼
Click pupil position on screen or press
and table to suitable position.
buttons to
align the camera.
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Automated Portable Retinal Camera (Optomed HALO)
User Manual
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Approach to the pupil by
◼
Align split bar by
buttons until split bar is visible
(Click on the
button, the fixation
mask plate will be removed. User can see the live retina video. )
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User Manual
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Enter the pupil by
◼
Use
click button
buttons until two spots are appeared
buttons to align two spots and
to capture
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Ver. D
Automated Portable Retinal Camera (Optomed HALO)
User Manual
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Click on the
button, the operation tips will be shown.
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Automated Portable Retinal Camera (Optomed HALO)
User Manual
4.2.4 Cornea capture mode
◼
Add forehead adaptor to forehead rest ( refer to item 7.1 forehead rest
installation)
◼
Click the
◼
Adjust Chinrest with
◼
Click pupil position on screen or press
button and then select the cornea capture mode.
and table to suitable position.
buttons to
align the camera.
◼
Use
buttons until the image is clear.
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User Manual
◼
Click
to capture
4.2.5 Send DICOM Image
When the selected patient which is found from DICOM server, the
DICOM sending widnow is displayed before user leaves the Capture
Image page. User can choose images and send them to DICOM server.
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Automated Portable Retinal Camera (Optomed HALO)
User Manual
4.2.6 Review captured image
Display the Visit List classified by capture date, and the capture time is
also displayed with each image. Operator can review images in this
window on a particular date.
Select Patient
Select Visit Date
Click on Image to enter Photo Viewer
◼
Multiple selections
⚫
Press and hold on image thumbnail can enter the multiple selection
mode.
⚫
Click image thumbnail to select image for batch delete or export.
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Automated Portable Retinal Camera (Optomed HALO)
User Manual
Selected Image
Montage
◼
Printer
Compare Export
Delete Cancel Select
Image delete
⚫
Click on
button, warning dialog will show. Click yes to delete
selected image. Be careful, Deleted image cannot restore!
◼
Montage
⚫
Click on
button, montage dialog will show.
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User Manual
Date List Switch
⚫
Click
button, the visit date list of selected patient will show.
Visit Date List
Click on image to assign it to candidate list
Candidate List
⚫
Click
Close
Deselect
Start Montage
button and the montage result will be shown.
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User Manual
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Image export
⚫
Click on
button, warning dialog will be shown and then choose
the destination folder, image compression format. The Export ID
means the file name should be included patient ID.
⚫
Press and hold the patient name from patient list, the export button
will be appeared. Click the
button and finish export options,
the all images of selected patient will be exported.
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User Manual
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Image comparison
⚫
Click on
button, comparison dialog will be shown
Date List Switch
Close
Reset
Redfree
⚫
Date list switch: Click
button, the visit date list of selected
patient will be shown.
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User Manual
Visit date list
Click on image to assign it to left or right frame
Left frame Right frame
◼
⚫
Reset: Click
⚫
Redfree: Click
button, all image settings are reset to default
button to show the redfree image
Printer
⚫
Click on
button, printer dialog will show. Click the PRINT to
print selected image.
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User Manual
Preview
Selected printer
Image Browse
Copy count
Selected paper
Comment
Perform print
Close printer dialog
⚫
Select two images and click on
button, printer dialog will show.
Click the PRINT to print selected images.
Preview
Selected printer
Image Browse
Copy count
Selected paper
Comment
Close printer dialog
Perform print
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4.2.7 Photo viewer
◼
Click image of Image List, the Photo Viewer will show. The Photo
Viewer includes below functions.
Image Information
Close
Contrast
Brightness
Negative
Red Free
RGB Separation
CD Ratio
Export
Reset
Back
Next
Image
⚫
Image information
ID: Patient ID
Eye: Captured eye
Mode: Capture mode
Time: Capture date and time
⚫
Close: Exit the photo viewer
⚫
Contrast: Adjust the selected image. The
level up and the
button is contrast
button is contrast level down.
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Level up Level down
⚫
Brightness: Adjust the selected image. The
brightness level up and the
button is
button is brightness level down.
Level up Level down
⚫
Negative: To do negative process for selected image
⚫
RedFree: Remove the red channel and convert to grayscale for
selected image.
⚫
RGB Separation: To do RGB channels separation and display in
color or grayscale mode. The
button is grayscale mode and the
is color mode.
Grayscale
⚫
Color
CD Ratio: To do disc and cup measurement. Below describes how
to measure the cup to disc ratio.
Step1. Use the pinch gesture to zoom in/out for region of interest
Step2. Click the CD Ratio button and click the
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Ver. D
Automated Portable Retinal Camera (Optomed HALO)
User Manual
Step3. Tap the border of disc until the blue line fit it.
Step4. Click the CD ratio button and click the
button.
Step5. Tap the border of cup until the yellow line fit it.
Step6. Click the CD ratio button and click the
button to save
the measurement result. The measurement is displayed on the
top-right side of Photo Viewer.
Cup to disc horizontal ratio
Cup to disc vertical ratio
Click the
⚫
button is for clear measurement.
Export: Export the current image
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User Manual
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Reset: Reset all measurement, scaling ratio, image position and
processing level etc…
Back/Next: Choose the next or previous image
The estimate CD ratio is obtained manually by operator and it is for reference
only.
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Automated Portable Retinal Camera (Optomed HALO)
User Manual
5 Specifications
5.1 Product specification
Function
Value/Type
Fundus image
Remark
Non-mydriatic, color image
Field of view
45 degrees
Illumination for retina
White LED
Strobe mode with flashing
image (Capture)
illumination.
Cornea Image (Capture) White LED
Strobe mode with flashing
illumination
Illumination during
NIR LED
alignment to patient’s
Central wavelength in the
range of 735-850nm
retina
Focus Diopter
-15D to +10 D
Without compensation lens
adjustment range
-30D to -10D or +5D to + With compensation lens
30D
Minimum pupil size
4 mm
Focus Adjustment
Auto/ Manual
Image sensor
CMOS 12 Megapixel
Working Distance
25mm from lens to
Split-image technique
Accuracy: +/- 0.5mm
cornea
Fixation
Internal
10 points
Alignment
Fully automatic 3D
tracking
Alignment Mode
Full Auto / Auto/
Manual
Chinrest
Motorized
Interface
USB 2.0 port
Input/ Output format
Image format: JPEG,
DICOM : optional
PNG
Operation Range
Front / Back: 40mm
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User Manual
Left/ Right: 90mm
Up/ Down: 30mm
Chinrest Range
Up/ Down: 50mm
Note-1:
USB interface is used to connect external laptop or tablet or PC.
Note-2:
Spec of external laptop or PC, the laptop or PC is dedicated for Optomed
Halo and for the risk of viruses and other malwares, users must install and
enable window defender and anti-virus software and follow the suggestion of
third- party software (including Windows defender and virus updates) to
update it.
➢
➢
➢
➢
Operating system: Windows 10 (64bits), OS limit to Windows.
Memory: >=2 GB;
Hard disk: >=500 GB;
USB I/O ports:>= 2 USB 2.0 ports
5.2 Environmental conditions
1) Operating conditions:
•
Temperature: 10°C to 35°C
•
Humidity: 30% to 90%RH
•
Atmospheric pressure: 800–1060 hPa
2) Storage conditions:
•
Temperature: -10–55°C
•
Relative humidity: 10–95%RH
•
Atmospheric pressure: 700–1060 hPa
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3) Transport conditions:
•
Temperature: -40–70°C
•
Relative humidity:10–95%RH
•
Vibration, sinusoidal: 10–500Hz, 0.5g
•
Shock:1/2 Sine Wave, 6 msec, 30G peak (packaged)
•
Bump: 1/2 Sine Wave, 6 msec,10G peak (packaged)
5.3 Electric rating
•
Source voltage :AC100-240V
•
Frequency :50-60Hz
•
Power input : < 65VA
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Automated Portable Retinal Camera (Optomed HALO)
User Manual
6 Maintenance
6.1 Lens cleaning
It is recommended to regularly clean the ocular lens of the Optomed Halo
on weekly basis or when needed.
6.1.1 Material required for ocular lens:
a) Diluted Acetone or Lens cleaning solution
b) Lens cleaning paper
6.1.2 Method:
Wet the lens paper with cleaning solution and wipe the ocular
lens with one pass in one direction. Discard the used lens paper.
Use a new sheet for each repeat cleaning until the ocular lens is
clean.
6.2 Chinrest and forehead rest
Soak the cleaning cloth or towel in disinfecting solution or use a wet
isopropyl alcohol cleaning paper pad. Wipe the chinrest and forehead
rest with the cleaning towels or paper pad before or after use.
The chinrest paper must be used, remove one piece for each patient.
When the chinrest paper has run out, pull off the chinrest pins and
replace it with new paper.
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User Manual
7 Software installation
Step 1. Copy the Optomed Halo installation package file to Windows desktop.
Step 2. Perform the Optomed Halo installation package, below installation
dialog will be shown.
Click here
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User Manual
Step 3. Click the “Install” button and wait for installation
Step 4. Perform the Optomed Halo program.
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User Manual
8 Installation and setup with external laptop
(Need to be executed by trained person or qualified agency).
8.1 Place carton box on the floor.
8.2 Remove the buckles
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8.3 Take off the Optomed Halo machine
8.4 Setup machine and relative cables
8.5 Connect the external laptop
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8.6 Remove lens cover
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