Nikon RetinaStation User manual

RetinaStation
User Manual
Manual del usuario
Manuel de l'utilisateur
Manuale utente
Benutzerhandbuch
Users are required to read through the accompanying documents before
using this instrument.
Los usuarios deben leer los documentos adjuntos antes de usar este
instrumento.
Les utilisateurs sont tenus de lire les documents d'accompagnement avant
d'utiliser cet instrument.
Gli utenti sono tenuti a leggere i documenti di accompagnamento prima di
utilizzare questo strumento.
Vor Verwendung dieses Instruments ist die Begleitdokumentation
vollständig zu lesen.
810-C1101-202 Ver. B

RetinaStation
User Manual
Page 1 Ver. B
English (en)
Content
1Introduction............................................................................................................ 2
1.1 Outline.....................................................................................................................2
1.2 Intended Use ...........................................................................................................2
1.3 Proper Use of the Instrument...................................................................................2
2Safety Information.................................................................................................. 3
2.1 Displays for Using the Instrument Safely..................................................................3
2.2 Symbols and Labels.................................................................................................5
2.3 Protective Packing Symbols.....................................................................................6
2.4 Product Labels.......................................................................................................11
2.5 Service Life............................................................................................................11
3Description of the Instrument............................................................................... 12
3.1 Introduction............................................................................................................12
3.2 Standard Accessories ............................................................................................13
4Introduction to the User Interface......................................................................... 14
4.1 Managing Patients.................................................................................................15
4.2 Capturing Images...................................................................................................23
5Specifications ...................................................................................................... 39
5.1 Product Specifications ...........................................................................................39
5.2 Environmental Conditions......................................................................................40
5.3 Electric Rating........................................................................................................40
6Maintenance........................................................................................................ 41
6.1 Cleaning the Lens..................................................................................................41
6.2 Chin Rest and Forehead Rest................................................................................41
6.3 LCD Monitor/Touch Panel......................................................................................41
6.4 Changing the Fuse.................................................................................................41
6.5 Cleaning the enclosure..........................................................................................41
7Updating the Software......................................................................................... 42

RetinaStation
User Manual
Page 2 Ver. B
English (en)
1 Introduction
1.1 Outline
The Nikon non-mydriatic fundus camera RetinaStation is a fast and easy to use auto 3D tracking retinal
imaging system. RetinaStation 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
RetinaStation provides non-mydriatic color retina and external images of the eye as an aid to clinicians in
the evaluation and diagnosis of eye disease. RetinaStation, which uses NIR LED as illumination when
aligning to the retina of a patient’s eyes, only provides images and does not provide any diagnostic or
pathological analysis or conclusions in any way. Furthermore, RetinaStation is not intended to be used
as the sole diagnostic aid in disease identification, classification or management.
1.3 Proper Use of the Instrument
1. RetinaStation is a medical instrument; it must be operated by properly trained and qualified person(s)
only. Its operation should be supervised by a physician.
2. Please be sure to read the user manual and understand the safety precautions before operating this
instrument.
3. Always enter patient information first.
4. Prepare the patient contact surfaces (forehead rest and chin rest) according to the cleaning method
described in this manual.
5. Immediately turn off the power switch of this instrument and disconnect the power cable if unusual
problems arise.
6. Clean the ocular lens frequently to ensure good image quality.
7. Properly adjust the height of the motorized adjustable table to ensure the comfort of the patient
during 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 provide comfortable viewing of
the fixation target without glare.
10. System functionality should be inspected once a year or whenever any repairs are made.

RetinaStation
User Manual
Page 3 Ver. B
English (en)
2 Safety Information
2.1 Displays for Using the Instrument Safely
Display
Meaning
WARNING
A WARNING indicates the presence of a hazard that could result in severe personal
injury.
CAUTION
A CAUTION indicates the presence of a hazard that could result in minor injury.
NOTE
A NOTE provides useful information for operation that is important.
WARNING
Accessory equipment that connects to the digital interfaces must be certified
according to the respective IEC standards (e.g., IEC 60950 for laptops or IEC
60601-1 for medical equipment). Furthermore, all configurations shall comply with
the system standards IEC 60601-1-1 and IEC 60601-1:2005.Any person who
connects/installs devices to/on the system is responsible for verifying compliance. If
in doubt, consult your local Nikon representative or distributor.
WARNING
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with a protective earth.
WARNING
Do not modify this instrument without the authorization of the manufacturer.
WARNING
THE RETINASTATION CANNOT REPLACE CLINICAL JUDGEMENTAND 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.
WARNING
The RetinaStation is a medical instrument. The software and hardware has been
designed in accordance with U.S., European and other international medical
instrument design and manufacturing standards. Unauthorized modification of the
RetinaStation 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
RetinaStation is not intended for home use and may not be stored or operated in
environment conditions other than those prescribed (see “Specifications”).

RetinaStation
User Manual
Page 4 Ver. B
English (en)
WARNING
Phototoxicity
Prolonged intense light exposure can damage the retina. Therefore, 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 is halved, twice the time is needed to
reach the maximum exposure limit.
WARNING
Do not obstruct the mains power switch or position the equipment where the
connection to the mains line can be accidentally disconnected.
WARNING
The instrument is not suitable for use in the presence of a flammable anesthetic
mixture with air, oxygen, or nitrous oxide.
WARNING
The RetinaStation has no special protection against the harmful ingress of water or
other liquids (classified IPX0). To avoid damaging the instrument and causing a
safety hazard, cleaning solutions, including water, should not be directly applied to
the instrument. Using a dampened cloth (without dripping) is a good method for
cleaning the exterior surface of the enclosure.
WARNING
The patient cannot touch any electrical device that is not powered by RetinaStation
with any part of his or her body while being examined. In addition, the RetinaStation
operator must not attempt to touch the patient and any electrical device that is not
powered by RetinaStation while examining the patient. Failure to do so could result
in electrical shock to the patient and/or operator.
WARNING
Do not connect any unspecified devices to the instrument. Doing so may result in
fire or electric shock. For details regarding purchasing accessories, please contact
your local Nikon representative or distributor.
CAUTION
Be sure to hold the bottom of the base when moving RetinaStation.
CAUTION
Do not operate the LCD monitor with wet hands or hard objects. Doing so many
damage the LCD monitor.
CAUTION
When adjusting the chin rest, be careful not to pinch the patient’s hands.
CAUTION
This instrument must be installed on a stable table. Do not install this instrument in a
location that is unstable or exposed to vibration.
CAUTION
Federal law restricts the sale of this instrument to sale by or on the order of a
physician or practitioner (CFR 801.109(b)(1)).
CAUTION
When adjusting the Fundus camera head, be careful not to pinch hands with the
LCD monitor/touch panel or Base.
CAUTION
When adjusting the Fundus camera head, be careful not to bring the Ocular lens
into contact with the patient's face.

RetinaStation
User Manual
Page 5 Ver. B
English (en)
2.2 Symbols and Labels
Presence of electrical shock hazard.
Note: Indicates the 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 the 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 4130175 Hannover, Germany
Serial number
Catalog number / part number
European conformity

RetinaStation
User Manual
Page 6 Ver. B
English (en)
2.3 Protective Packing Symbols
The protective packing symbols specify the handling requirements and the transportation 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 it has been determined that this instrument is ready for disposal, it must be recycled in
accordance with the requirements of the policies and procedures of the corresponding country.
Do not dispose of this instrument as general waste.

RetinaStation
User Manual
Page 7 Ver. B
English (en)
Product Compliance
93/42/EEC/M5 Medical Device Directive
Indicates this equipment contains Type B applied parts
The RetinaStation 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 RetinaStation device has been tested to comply with the emission and immunity
requirements of EN60601-1-2. The RetinaStation is intended for use in an electromagnetic
environment where radiated RF disturbances are not beyond the standard defined in
EN60601-1-2.
Certification: Under IEC 60601-1
Guidance and manufacturer’s declaration – electromagnetic emissions
The RetinaStation is intended for use in the electromagnetic environment specified below. The customer or the
user of the RetinaStation should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The RetinaStation uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference to nearby electronic equipment.
RF emissions
CISPR 11
Class A
The RetinaStation 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

RetinaStation
User Manual
Page 8 Ver. B
English (en)
Guidance and manufacturer’s declaration – electromagnetic immunity
The RetinaStation is intended for use in the electromagnetic environment specified below. The customer or the
user of the RetinaStation 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
2 kV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital
environment.
1 kV for
input/output lines
1 kV for
input/output
lines
Surge
IEC 61000-4-5
1 kV line(s) to
line(s)
1 kV line(s) to
line(s)
Mains power quality should be that of a
typical commercial or hospital
environment.
2 kV line(s) to
earth
2 kV line(s) to
earth
Interruptions and
voltage variations in
power supply input lines
IEC 61000-4-11
<5% UT(>95% dip
in UT) for 0.5 cycle
<5% UT(>95% dip
in UT) for 0.5 cycle
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
RetinaStation requires continued operation
during power mains interruptions, it is
recommended that the RetinaStation be
powered from an uninterruptible power
supply or a battery.
40% UT(60% dip in
UT) for 5 cycles
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip
in UT) for 5 sec
<5% UT(>95% dip
in UT) for 5 sec
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 UTis the AC mains voltage prior to application of the test level.