Optomed Polaris User manual
Polaris
User Manual
Reading through accompanying documents is a
mandatory action before using this equipment
810-C1101-434 Ver. A
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
1
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 18
2.5 Service life 18
2.6 Cybersecurity information 18
2.7 Cybersecurity functions 19
2.8 Data back up 20
3Instrument description 21
3.1 Introduction 21
3.2 Standard accessories 23
4Log in and introduction of user interface 24
4.1 Patient management 31
4.2 Capture image 36
5Specifications 55
5.1 Product specification 55
5.2 Environmental conditions 57
5.3 Electric rating 58
5.4 Fuse specification 58
6Maintenance 59
6.1 Lens cleaning 59
6.2 Chinrest and forehead rest 59
6.3 LCD monitor/Touch panel 59
7Installation 60
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
3
1 Introduction
1.1 Outline
The Automated non-mydriatic fundus camera Optomed Polaris is an auto
3D tracking, fast and easy to use retinal imaging system. Optomed Polaris
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 Polaris 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 Polaris 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 Polaris 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.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
4
1.4 Proper instrument use
1. Optomed Polaris 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 systems’ functionality should be conducted once a year
or whenever any repairs are made.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
5
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 POLARIS CANNOT
REPLACE CLINICAL JUDGEMENT AND IS
INTENDED TO BE USED ONLY IN
CONJUCTION WITH OTHER CLINICAL
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
6
TOOLS CONSIDERED TO BE THE
STANDARD OF CARE FOR MEASUREMENT
AND DIAGNOSIS OF THE EYE.
WARNING
The Optomed Polaris is a medical device. The
software and hardware have been designed in
accordance with U.S., European and other
international medical device design and
manufacturing standards. Unauthorized
modification of the Optomed Polaris 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 Polaris 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.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
7
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 Polaris 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 Polaris with
any part of his or her body while being
examined. In addition, the Optomed Polaris
operator must not attempt to touch the patient
and any electrical device that is not powered by
Optomed Polaris 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.
CAUTION
Be sure to hold the bottom of the base when
Optomed Polaris is moved.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
8
CAUTION
Do not operate the LCD monitor with wet hands
or hard objects. The LCD monitor may be
damaged.
CAUTION
When adjusting chinrest, be careful not to pinch
the patient’s hand.
CAUTION
The device needs to install on the stable table.
Do not install in location that is 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
To ensure cleanliness, replace the chinrest
paper whenever changing patients.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
9
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
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
10
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.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
11
Product compliance
Indicates this equipment contains Type B applied parts
The Optomed Polaris 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).
Continuous Operation – Mode of operation
Electromagnetic Compatibility (EMC): EN 60601-1-2
The Optomed Polaris device has been tested to comply with
the emission and Immunity requirements of EN60601-1-2.
The Optomed Polaris is intended for use in an
electromagnetic environment where radiated RF
disturbances are not beyond the standard defined in
EN60601-1-2.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
12
Certification: under IEC 60601-1
Guidance and manufacturer’s declaration – electromagnetic emissions
The Optomed Polaris is intended for use in the electromagnetic environment specified below. The
customer or the user of the Optomed Polaris should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The Optomed Polaris 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 Polaris is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
13
Guidance and manufacturer’s declaration – electromagnetic immunity
The Optomed Polaris is intended for use in the electromagnetic environment specified below.
The customer or the user of the Optomed Polaris should assure that it is used in such an
environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
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
± 2 kV for power
supply lines
± 1 kV for
input/output
lines
± 2 kV for power
supply lines
± 1 kV for
input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be
that of a typical commercial or
hospital environment.
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the Optomed Polaris
requires continued operation
during power mains
interruptions, it is
recommended that the
Optomed Polaris should be
powered from an
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
14
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
uninterruptible power supply or
a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
15
Guidance and manufacturer’s declaration – electromagnetic immunity
The Optomed Polaris is intended for use in the electromagnetic environment specified
below. The customer or the user of the Optomed Polaris should assure that it is used in
such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment –
guidance
Conducted
RF
IEC 61000-
4-6
Radiated
RF
IEC 61000-
4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Optomed Polaris, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d = 1,2
d = 1,2 80 MHz to 800 MHz
d = 2,3 800 MHz to 2,5 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).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a should
be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity of
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
16
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, 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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Optomed Polaris is
used
exceeds the applicable RF compliance level above, the Optomed Polaris should be
observed to
verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the Optomed Polaris.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
17
Recommended separation distances between
portable and mobile RF communications equipment and the Optomed Polaris
The Optomed Polaris is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Optomed
Polaris can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
Optomed Polaris 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
80 MHz to 800
MHz
d = 1,2
800 MHz to 2,5 GHz
d = 2,3
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.
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
18
2.4 Product labels
Optomed Polaris system labels:
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 an Optomed representative
or distributor.
2.5 Service life
The service life of Optomed Polaris 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 Polaris system.
2.6.2 System overview
Non-Mydriatic Fundus Camera (Optomed Polaris) - User Manual
19
The Optomed Polaris 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
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 Polaris, 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 Polaris 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
Table of contents
Other Optomed Medical Equipment manuals
