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
Page 1 Ver. D
Content
1Introduction 3
1.1 Outline 3
1.2 Intended use 3
1.3 Indication for Use 3
1.4 Proper instrument use 4
2Safety information 5
2.1 Displays for safety use 5
2.2 Symbols and labels 9
2.3 Protective packing symbols 10
2.4 Product labels 17
2.5 Service life 17
2.6 Cybersecurity information 17
2.7 Cybersecurity functions 18
2.8 Data back up 19
3Instrument description 20
3.1 Introduction 20
3.2 Standard accessories 21
4Log in and introduction of user interface 22
4.1 Patient management 29
4.2 Capture image 34
5Specifications 55
5.1 Product specification 55
5.2 Environmental conditions 56
5.3 Electric rating 57
6Maintenance 58
6.1 Lens cleaning 58
6.2 Chinrest and forehead rest 58
7Software installation 59
8Installation and setup with external laptop 61
8.1 Place carton box on the floor. 61

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User Manual
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8.2 Remove the buckles 61
8.3 Take off the Optomed Halo machine 62
8.4 Setup machine and relative cables 62
8.5 Connect the external laptop 62
8.6 Remove lens cover 63

Automated Portable Retinal Camera (Optomed HALO)
User Manual
Page 3 Ver. D
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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User Manual
Page 4 Ver. D
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.

Automated Portable Retinal Camera (Optomed HALO)
User Manual
Page 5 Ver. D
2 Safety information
2.1 Displays for safety use
Display
Meaning
WARNING
“WARNING” indicates the presence of a hazard
that could result in severe personal injury.
CAUTION
“CAUTION” indicates the presence of a hazard
that could result in minor injury.
NOTE
“NOTE” provides useful information for
operation which is important.
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
To avoid risk of electric shock, this equipment
must only be connected to the supply mains
with protective earth.
WARNING
Do not modify this equipment without
authorization of the manufacturer.
WARNING
THE Optomed Halo CANNOT REPLACE
CLINICAL JUDGEMENTAND IS INTENDED
TO BE USED ONLY IN CONJUCTION WITH
OTHER CLINICAL TOOLS CONSIDERED TO
BE THE STANDARD OF CARE FOR
MEASUREMENTAND DIAGNOSIS OF THE
EYE.

Automated Portable Retinal Camera (Optomed HALO)
User Manual
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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.

Automated Portable Retinal Camera (Optomed HALO)
User Manual
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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.

Automated Portable Retinal Camera (Optomed HALO)
User Manual
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CAUTION
Be sure to hold the bottom of the base when
Optomed Halo is moved.
CAUTION
When adjusting chinrest, be careful not to pinch
the patient’s hand.
CAUTION
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.

Automated Portable Retinal Camera (Optomed HALO)
User Manual
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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

Automated Portable Retinal Camera (Optomed HALO)
User Manual
Page 10 Ver. D
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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User Manual
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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 HaloTM device has been tested to comply
with the emission and Immunity requirements of
EN60601-1-2:2015 (4th edition). The Optomed HaloTM 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).

Automated Portable Retinal Camera (Optomed HALO)
User Manual
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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
CISPR 11
Group 1
The Optomed Halo uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class A
The Optomed Halo is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies

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User Manual
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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
test level
Compliance level
Electromagnetic
environment-guidance
(for professional healthcare
environment)
Electrostatic
discharge(ESD)
IEC 61000-4-2
Contact:±8 kV
Air±2 kV,±4 kV,±8 kV,
±15 kV
Contact:±8 kV
Air±2 kV,±4 kV,±8
kV,±15 kV
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%
Electrical fast
transient/burst
IEC 61000-4-4
+ 2kV for power supply
lines
+ 1kV for input/output
lines
+ 2kV for power supply
lines
Not applicable
Mains power quality should be that
of a typical professional healthcare
environment.
Surge
IEC 61000-4-5
+ 0.5kV, +1kV line(s) to
line(s)
+ 0.5kV, +1kV,+ 2kV
line(s) to earth
+ 0.5kV, +1kV line(s) to
line(s)
+ 0.5kV, +1kV,+ 2kV
line(s) to earth
Mains power quality should be that
of a typical professional healthcare
environment.
Voltage Dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle|
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25 cycles
Voltage interruptions:
0 % UT; 250 cycles
Mains power quality should be that
of a typical professional healthcare
environment. If the user of the
Optomed Halo requires continued
operation during power mains
interruptions, it is recommended that
the Optomed Halo be powered from
an uninterruptible power supply or a
battery.
Power frequency(50,
60 Hz) magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz
The Optomed Halo power frequency
magnetic fields should be at levels
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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User Manual
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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
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms:
0,15 MHz –80 MHz
6 Vrms:
in ISM bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz –2,7 GHz
80 % AM at 1 kHz
3 Vrms:
0,15 MHz –80 MHz
6 Vrms:
in ISM bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz –2,7 GHz
80 % AM at 1 kHz
Portable and mobile RF communications
equipment should be used no closer to any part of
the Optomed Halo including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P
d = 1,2 √P80MHz to 800 MHz
d = 2,3 √P800MHz to 2,7 GHz
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 Halocan 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
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d =1,2√P
80 MHz to 800 MHz
d =1,2√P
800 MHz to 2,7 GHz
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 din 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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User Manual
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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.
Test frequency
(MHz)
Band a)
(MHz)
Service a)
Modulation b)
Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance LEVEL
(V/m)
(for professional
healthcare)
385
380 –390
TETRA 400
Pulse
modulation b)
18 Hz
1,8
0,3
27
27
450
430 –470
GMRS 460,
FRS 460
FM c)
±5 kHz deviation
1 kHz sine
2
0,3
28
28
710
704 –787
LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2
0,3
9
9
745
780
810
800 –960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2
0,3
28
28
870
930
1 720
1 700 –
1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
2
0,3
28
28
1 845
1 970
2 450
2 400 –
2 570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2
0,3
28
28
5 240
5 100 –
5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2
0,3
9
9
5 500
5 785
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) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) 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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User Manual
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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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User Manual
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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.