Sirius

COSTRUZIONE STRUMENTI OFTALMICI
Corneal Topographer/Tomograph
INSTRUCTIONS FOR USE
Sirius+
Via degli Stagnacci 12/E | 50018 Scandicci (FI) | ITALY

Phone: +39 055 722191 | Fax: +39 055 721557
[email protected] | www.csoitalia.it
IFU327EN02.04 - 11/2022
0051
EN
Sirius+ | IFU327EN02.04 - 11/2022
1 INTRODUCTION ......................................................................................... 3
1.1 SYMBOLS .......................................................................................................... 3
1.1.1 Device symbols ..................................................................................................... 4
1.2 GENERAL WARNINGS ........................................................................................... 4
1.3 NORMATIVE REFERENCES ..................................................................................... 5
1.3.1 EU Directives ........................................................................................................ 5
1.3.2 Technical standards .............................................................................................. 5
1.3.3 Quality management system standards ............................................................... 5
1.4 WARRANTY ....................................................................................................... 6
1.5 MANUFACTURER IDENTIFICATION ........................................................................... 7
2 SAFETY....................................................................................................... 8
2.1 SAFETY WARNINGS .............................................................................................. 8
2.2 DEVICE IDENTIFICATION ...................................................................................... 10
2.2.1 Registration data in the List of Medical Devices ................................................. 10
2.2.2 Device data plate................................................................................................ 10
2.2.3 Power supply unit data plate .............................................................................. 11
2.3 INTENDED USE.................................................................................................. 11
2.4 MEDICAL DEVICE CLASSIFICATION ......................................................................... 16
2.5 ELECTROMEDICAL DEVICE CLASSIFICATION ............................................................... 17
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 17
2.7 DISPOSAL AT THE END OF THE USEFUL LIFE .............................................................. 18
2.8 MANUFACTURER DECLARATIONS .......................................................................... 20
2.8.1 Electromagnetic emissions ................................................................................. 20
3 DEVICE DESCRIPTION .............................................................................. 23
3.1 SUPPLY DESCRIPTION ......................................................................................... 23
3.1.1 Sirius+ Device ..................................................................................................... 25
3.1.2 Power supply unit ............................................................................................... 26
3.1.3 Chin rest ............................................................................................................. 27
3.1.4 Ophthalmic table ................................................................................................ 28
3.1.5 Personal Computer ............................................................................................. 28
3.2 TECHNICAL DATA .............................................................................................. 30
4 DEVICE USE ............................................................................................. 32
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 32
4.2 HOW TO CONNECT THE DEVICE............................................................................. 35
4.3 HOW TO ARRANGE THE ELECTRIC CABLES ................................................................ 36
4.4 HOW TO TURN ON THE DEVICE ............................................................................. 37
4.4.1 How to perform device calibration ..................................................................... 37
4.4.2 How to create a new patient .............................................................................. 39
4.4.3 How to create a new examination...................................................................... 39
4.5 HOW TO ADJUST THE CHIN CUP ............................................................................ 40
4.6 HOW TO ACQUIRE AN IMAGE ............................................................................... 43
4.7 HOW TO REPLACE CHIN CUP PAPERS ...................................................................... 44
4.8 HOW TO TURN OFF THE DEVICE ............................................................................ 45
This document is the property of C.S.O. SRL.

Any reproduction, even partial, it is prohibited.
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5 ORDINARY MAINTENANCE ...................................................................... 46

5.1 SAFETY WARNINGS ........................................................................................... 46
5.2 CLEANING AND DISINFECTION .............................................................................. 46
5.2.1 Recommended products for cleaning and disinfection ....................................... 47
5.2.2 Classification of the criticality of the device ....................................................... 48
5.2.3 Device cleaning .................................................................................................. 48
5.2.4 Cleaning the applied parts.................................................................................. 49
5.2.5 Cleaning the optical components ....................................................................... 49
5.3 DEVICE CALIBRATION .........................................................................................
49
5.4 SPARE PARTS AND ACCESSORIES LIST ..................................................................... 50
5.5 TROUBLESHOOTING .......................................................................................... 51

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1 INTRODUCTION
The device is the result of a long research period, conducted with
experts to ensure the product's technical innovation, quality and
design.
The device can be easily used thanks to the guided manual acquisition
and electronic control of all device functions.
1.1 SYMBOLS
Within the instructions for use, on the package or on the device, the
following symbols may be displayed:
Symbol Meaning
Caution
Danger of electric shock
Read the instructions for use
General obligation
Note. Useful information for the user
General prohibition sign
Manufacturer
CE Marking (Directive 93/42/EEC)

Identification number of the notified body (IMQ)

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Medical device
Waste disposal in compliance with Directives 2012/19/EU (WEEE)

and 2011/65/EU (RoHS II)
1.1.1 DEVICE SYMBOLS
Symbol Meaning
Type B applied part
1.2 GENERAL WARNINGS

THESE INSTRUCTIONS FOR USE REFER TO THE SIRIUS+ DEVICE
("DEVICE" FROM NOW ON).
THE ORIGINAL TEXT IS IN ITALIAN.
Before using the device or after a long period of non-use, read these
instructions for use carefully. Follow the directions provided in the
instructions for use and reported on the device.
Always keep these instructions for use in an accessible and nearby
place. If you decide to sell this device to others, remember to include
these instructions, complete and readable.
Keep the original box and packaging, as the free-of-charge service
does not cover any damage resulting from inadequate packaging of
the device when it is sent back to an authorised Service Centre.
Verify any potential damage to the device caused by
transport/storage prior to using the device.
It is forbidden to reproduce, totally or partially, texts or images

contained in these instructions for use without the written
authorization of the Manufacturer.

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The Manufacturer reserves the right to modify the contents of the

instructions for use without advance notice.
1.3 NORMATIVE REFERENCES

1.3.1 EU DIRECTIVES
- Directive 93/42/EEC and subsequent modifications and additions
concerning medical devices
- Regulation (EU) 2017/745 of the European Parliament and Council
of 5 April 2017 on medical devices (to the extent applicable)
- Directive 2012/19/EU on waste from electrical and electronic
equipment (WEEE)
1.3.2 TECHNICAL STANDARDS
- IEC 60601-1: 2005 + A1:2012 - "Medical electrical equipment - Part
1: General requirements for basic safety and essential
performance"
- EC 60601-1-2:2014 Edition 4 - "Collateral Standard:
Electromagnetic disturbances - Requirements and tests"
- UNI EN ISO 15004-1:2009 Ophthalmic Instruments. Fundamental
requirements and test methods - Part 1: General requirements
applicable to all ophthalmic devices
- UNI EN ISO 15004-2:2007 Ophthalmic Instruments. Fundamental
requirements and test methods - Part 2: Light hazard protection.
- UNI CEI EN ISO 14971:2012 Medical devices. Application of risk
management to medical devices.
- UNI EN ISO 19980:2012 - Ophthalmic instruments - Corneal
topographers
1.3.3 QUALITY MANAGEMENT SYSTEM STANDARDS
- UNI CEI EN ISO 13485:2016 “Medical devices. Quality management
systems - Requirements for regulatory purposes".

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1.4 WARRANTY
The Manufacturer is responsible for the compliance of the device with
EU Directive 93/42/EEC as amended by 2007/47/EC for:
- features
- safety and reliability
- CE marking
The Manufacturer refuses any responsibility for:
- installation and start-up that is not carried out in compliance with
the directions and precautions reported in the instructions for use
- use that fails to comply with the instructions for use or precautions
reported in the instructions for use
- use of accessories or spare parts not provided or suggested by the
Manufacturer
- repairs and safety controls not carried out by expert, qualified and
trained personnel authorised by the Manufacturer
- failure of the electrical system of the premises where the device is
installed to comply with the technical standards, laws and
regulations in force in the country where the device is installed
- direct or indirect consequences or damage to objects or persons
caused by the improper use of the device or erroneous clinical
analysis originating from its use
The Manufacturer guarantees the device for 24 months after the
invoice date. The warranty covers the substitution by the
Manufacturer or an authorised Service Centre of components and
materials and the corresponding labour. Shipping and transport fees
are to be paid by the client.
The warranty does not cover:
- repairs of malfunctions caused by natural disasters, mechanical
shocks (falls, collisions, etc.), electrical system defects, negligence,
misuse, maintenance or repairs carried out with non-original
materials
- any other misuse or use not intended by the Manufacturer
- damage caused by service failings or inefficiencies due to causes or
circumstances out of the Manufacturer's control

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- the wearing out and/or deterioration of parts due to normal use

and those that might break due to misuse or maintenance carried
out by personnel not authorised by the Manufacturer.
To request maintenance interventions or obtain technical information
about the device, contact an authorised Service Centre or the device
Manufacturer directly.
The client will not be refunded for damage caused by device

stoppage.
1.5 MANUFACTURER IDENTIFICATION

C.S.O. SRL
Costruzione Strumenti Oftalmici
Via degli Stagnacci, 12/E
50018 - Scandicci (FI) - ITALY
phone: +39-055-722191 - fax +39-055-721557
[email protected]
www.csoitalia.it

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2 SAFETY
2.1 SAFETY WARNINGS
DANGER
Danger of electric shock. Do not let water fall on the device. Do not
immerse the device in water or other liquids.
DANGER
Danger of electric shock. If the power supply cables are damaged,
they shall be replaced by an authorised Service Centre to prevent
any risk.
DANGER
Danger of electric shock. Unplug the power supply cable from the
power socket before disinfecting or cleaning the device and before
any maintenance operation.
CAUTION
Do not use the device if visibly damaged. Periodically inspect the
device and connection cable to check for any signs of damage.
CAUTION
Always keep the device out of the reach of children.
CAUTION
Danger of falling device. Do not leave loose cables which may
represent an obstacle or danger for the patient or operator.
CAUTION
Danger of stumbling and falling. Do not leave the power or
connection cables loose in places where people may walk.
CAUTION
Risk of electric shock. Do not touch the power supply cables with
wet hands.

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CAUTION
Risk of electric shock. Do not leave the power supply cables in
contact with sharp edges or cutting parts. Always collect and fasten
the power supply cables.
CAUTION
If you notice a strange odour or smoke coming out of the device or
if it emits heat, turn it off immediately. Do not continue to use a
damaged device or damaged part. Danger of injuries.
CAUTION
The power grid shall have a residual-current device (IΔn=30mA) and
circuit breaker (Vn=230V) to protect the device. Place the device in
such a way that the power socket is easily accessible.
It is forbidden to carry out any technical operation on the device that

is not cited or described in these instructions for use.
It is forbidden to place the device in humid, dusty places or

environments subject to sudden variations in temperature and
humidity.
It is forbidden to use any extension cable not authorised by the

device Manufacturer.
It is forbidden to use the device outdoors.
The device does not generate and does not receive any
electromagnetic interference if placed near other electrical
appliances. No preventive or corrective actions are required.

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2.2 DEVICE IDENTIFICATION

2.2.1 REGISTRATION DATA IN THE LIST OF MEDICAL DEVICES
The device registration data can be verified on the Italian Ministry of
Health website at this page:
Ministero della Salute - Ricerca dispositivi
2.2.2 DEVICE DATA PLATE
Fig. 1 - Data plate position
Pos Description
A Device data plate
Fig. 2 - Device data plate

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2.2.3 POWER SUPPLY UNIT DATA PLATE
Fig. 3 - PSP2402 power supply unit data plate
2.3 INTENDED USE

Sirius+ is a medical device used for ophthalmological diagnostics. The
device combines optical reflection topography with a Placido disk and
Sheimpflug tomography of the anterior segment.
The device has been designed for the acquisition and processing of 25
images of the cornea section and anterior chamber.
The device provides information on pachymetry, elevation, curvature
and dioptric power of both corneal surfaces over a diameter of 12 mm
and biometric measures of the anterior chamber.
Two video cameras allow for "live" filming of the cornea and anterior
chamber of the eyeball and their visualisation on the computer screen.
In addition to clinical diagnostics of the anterior segment, the most
common fields of application are refractive and cataract surgery.
An accurate measurement of the pupil diameter in scotopic, mesopic
and photopic conditions in a dynamic way and their integration with
the corneal map allow for photoablative surgery planning and follow-
up.
Based on the pachymetric map and corneal altimetric data, the device
enables intrastromal ring segment planning for the correction of
refractive defects and some forms of keratoconus.
Corneal topography
The device provides information on pachymetry, elevation, curvature
and refractive power of both corneal surfaces over a diameter of 12
mm.

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Pupillography
The pupillography module is completely integrated with the
topography and enables the user to:
- follow the pupillometry measurement in scotopic light conditions
in order to evaluate the maximal pupil extension and eye area
dimensions that shall be set up for a treatment.
- Perform the pupillometry measurement in scotopic light conditions
(0.04 lux).
- Perform the pupillometry measurement in mesopic light conditions
(4 lux).
- Perform the pupillometry measurement in photopic light
conditions (50 lux).
- Perform the dynamic pupillometry measurement starting from 400
lux and turning off the light source so that the pupil dilates to its
maximal extension.
- Evaluate pupil decentralisation with respect to the corneal vertex
for each of the conditions described above and the pupil centre
drift during dilation.
Meibography
The device allows for analysis of the Meibomian glands using a non-
invasive method. The meibography is performed through infrared
illumination that enhances contrast, magnifying the anatomic
structure of the glands without causing any discomfort to the patient.
An additional negative lens is provided with the device. Magnetically

apply the lens to the device in order to increase the image shooting
range.
Analysis of the tear film

The device's Placido disk enables advanced tear film analysis and the
evaluation of the NI-BUT (Non-Invasive Break-up Time).

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Videokeratoscopy
The device is provided with a white light source for acquiring colour
images or videos and with a cobalt blue light source for the
fluorescence analysis of the ocular surface and clearance of rigid
contact lenses.
The supplied yellow filter, to be applied magnetically to the device,
improves image visualisation during the excitation of the fluorescein.
The change of magnification is very useful for the acquisition of images
with a wide visual field of the tear meniscus and eye redness by means
of the additional negative lens supplied, to be magnetically applied to
the device.
The device is provided with a diffusion filter as well, to be magnetically
applied to the Placido disk, which permits analysis of the tear lipid
layer pattern.
Corneal aberrometry
The device enables the analysis of corneal aberrations. It is possible to
select the anterior, posterior or total corneal section for different
pupillary diameters. The OPD/WFE map and visual simulations (PSF,
MTF and image convolution) can help understand and explain the
patient’s visual discomfort.
IOL calculation module
An IOL calculation module based on the Ray-Tracing Technique is
available which, regardless of the clinical status of the cornea, provides
the values of the spherical and toric power of the intraocular lens. This
enables the planning of surgery to correct refractive defects by means
of intraocular lens implants.
Glaucoma screening
The device enables glaucoma screening and provides measurements of
iridocorneal angles and corneal pachymetry. Together with the most
common IOP correction formulas, these values are useful in diagnosing
several diseases which may depend on the shape of the anterior
chamber.

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Keratoconus screening
An efficient keratoconus screening system, clinically validated,
provides an indication of the risk of ectasia, underlining the cases
which have a greater possibility of complications.
Contact lenses application module
The contact lens application module allows for the simulation of rigid
contact lenses thanks to a vast database of international models and
manufacturers.
Dry Eye Report
The Dry Eye Report provides an overall evaluation of the patient’s
clinical conditions, aimed at diagnosing tear film dysfunctions. The
evaluation is based on:
- Ocular Surface Disease Index (OSDI)
- Eye redness analysis
- Meibomian glands analysis
- Tear meniscus analysis
- NiBUT.
Additional device features with the application software
Together with the application software, the device allows for:
- Guided manual acquisition
- Management of patient data and the possibility of personalizing
research and statistics
- Advanced ring editing system which permits modification of the
position of the edges in order to provide a proper reconstruction,
even on distorted surfaces.
- Availability of the following maps: sagittal curvature map,
tangential curvature map, elevation, refractive power, Gaussian
curvature map, corneal pachymetry.
- Screens and summaries which allow personalisation of the device
depending on the user:
- Four map summary
- Single map screen
- Keratoconus summary
- Six map summary

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- Advanced altimetry and Zernike summary

- Adjustable corneal wavefront analysis of the pupil. It
includes maps of the most common aberrations
- Corneal wavefront analysis with an optical quality summary,
with reference to the anterior corneal section, with PSF,
Spot Diagram, MTF and vision simulation for the analysed
wavefront
- Autofit for the search for the best contact lens, based on the
altimetry measure of the cornea, performed on a database of more
than 50,000 lenses
- The possibility of personalising the contact lens and simulating its
application
- Tools for the follow-up examination, with differential maps with 2
or 3 elements
- Tools for the follow-up examination with comparison of up to 4
different maps
- A wide-ranging series of synthetic descriptors of the properties of
the cornea, including:
- Sim-K to simulate the measurement of a fixed-target
ophthalmometer (for the anterior surface)
- Principal corneal meridians in the 3 mm, 5 mm and 7 mm
zones
- Flatter and steeper hemimeridians in the 3 mm, 5 mm and 7
mm zones
- Peripheral degrees
- Pupil decentralisation, pupil diameter, and corneal diameter
size
- Keratorefractive indices calculated in the pupil area for an
assessment of the patient's visual quality
- Keratoconus screening index for diagnosis and follow-up
- Dry Eye Report
For system requirements, read section "Personal Computer” on

page 28.

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The device shall only be used by specialist practitioners and

professionals (such as optometrists), within the limits of the law and
regulations for the exercise of the profession.
Report any serious incident that has occurred in relation to the device to
the manufacturer and the competent authority of the Member State
where the user and/or patient is established.
Patient area: any volume in which a patient with applied parts may
intentionally or unintentionally come into contact with other
electromedical devices or electromedical systems, masses or foreign
masses, or other people in contact with these elements.
Fig. 4 - Patient area
2.4 MEDICAL DEVICE CLASSIFICATION

Technical data Value
Classification based on annexe IX of
Directive 93/42/EEC and subsequent Class IIa
modifications

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2.5 ELECTROMEDICAL DEVICE CLASSIFICATION

Classification based on the IEC 60601-1:2005 + A1:2012 technical
standard
Type of protection against direct and
Class I
indirect contacts
Applied parts Type B
IP20 (no protection against infiltration
Degree of protection against humidity
by liquids)
Sterilisation or disinfection method This device can be disinfected
Degree of protection in the presence
of anaesthetics or inflammable No protection
detergents
Degree of electrical connection Devices with part applied to the
between device and patient patient
Use conditions Continuous functioning
2.6 ENVIRONMENTAL CONDITIONS

Phase Technical data Min Max
Transport Temperature -40°C +70°C
Atmospheric pressure 500 hPa 1060 hPa
Relative humidity 10% 95%
Storage Temperature -10°C +55°C
Use Temperature +10°C +35°C
Phase Technical data Min
Vibration Sinusoidal 10 Hz to 500 Hz, 0.5g
Shock 30g duration 6ms
Bump 10g duration 6ms

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CAUTION
Danger of damage to the device. During transport and storage, the
device may be exposed to the environmental conditions described
for a maximum period of 15 weeks, if kept in the original package.
2.7 DISPOSAL AT THE END OF THE USEFUL LIFE

Instructions for the correct disposal of the device pursuant to
European Directives 2012/19/EU and 2011/65/EU regarding the
reduction of the use of dangerous substances in electrical and
electronic equipment, as well as waste disposal.
At the end of its useful life, the device shall not be disposed of with
urban waste. The device may be delivered to designated waste
sorting centres set up by the municipal administration or to dealers
that offer this service. Separately disposing of an electrical device
prevents potential negative consequences for the environment and
health caused by improper disposal and allows the materials it is
made of to be recycled so as to attain significant savings in energy
and resources. The data plate of the device displays the symbol of
the crossed-out wheeled bin. The crossed-out wheeled bin symbol
indicates the obligation to collect and dispose of electrical and
electronic equipment separately at the end of their useful life.
The user shall consider the potentially dangerous effects for the
environment and human health arising from the improper disposal
of the whole device or its parts.
Should the user wish to dispose of the device at the end of its useful
life, the Manufacturer facilitates its potential reuse and recovery and
the recycling of the materials contained therein. This prevents the
release of hazardous substances into the environment and promotes
the conservation of natural resources. Before disposing of the device,
it is crucial to take into consideration European and national
regulations, which prescribe the following:
- not to dispose of it as urban waste, but separate it out, turning to a
firm specialised in the disposal of electrical/electronic equipment
or to the local administration in charge of waste collection.

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- in the event that a new device is purchased from the same

Manufacturer to replace an old one placed on the market before
13 August 2005, equivalent and with the same functions as the
new device, the Distributor or Manufacturer is legally required to
collect the old device.
- if the user decides to dispose of a used device placed on the
market after 13 August 2005, the Distributor or Manufacturer is
required to collect it.
- the Manufacturer provides for the processing and recycling of the
used device, joining a technological waste consortium and paying
for the corresponding costs.
The Manufacturer is available to provide the user with information
regarding the dangerous substances contained in the device, the
recycling of these substances and the potential reuse of the used
device.
Strict administrative sanctions for transgressors are provided for by
law.
For specific information about disposal in countries other than Italy,
contact your local Dealer.

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2.8 MANUFACTURER DECLARATIONS

2.8.1 ELECTROMAGNETIC EMISSIONS
The device is designed to be used in a room with the following
electromagnetic characteristics:
Emission test Compliance Electromagnetic environment
The device uses radio frequency

energy only for its internal functioning.
Radio frequency The device's electromagnetic
Assembly 1
emission. CISPR 11 emissions are very low and should not
cause interference with nearby
electronic devices.
The device may be used in all

environments, including domestic
Radio frequency
Class B ones. The device can be connected
emission. CISPR 11
directly to a low-voltage power grid
like that of residential buildings.

Harmonic emissions. IEC
Class A ones. The device can be connected
61000-3-2

Limitation of voltage
changes, voltage
Compliant ones. The device can be connected
fluctuations and flicker.
IEC 61000-3-3

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IEC 60601-1-2 Compliance Electromagnetic

Immunity test
test level level environment
Floors shall be wood,
concrete or ceramic
Electrostatic ±6 kV in ±6 kV in tile. If the floors are
discharge. IEC 61000- contact. ±8 kV contact. ±8 covered with
4-2 in air kV in air synthetic material, the
relative humidity shall
be at least 30%.
±2 kV for power ±2 kV for

The power grid shall
Temporary/rapid supply lines. ±1 power
be that of a typical
sequences of electrical kV for supply lines.
commercial or
pulses. IEC 61000-4-4 input/output Not
hospital environment.
lines applicable
±1 kV
±1 kV The power grid shall
differential
differential be that of a typical
Impulse. IEC 61000-4-5 mode. ±2 kV
mode. ±2 kV commercial or
common
common mode hospital environment.
mode
The power grid shall
be that of a typical
commercial or
<5% Un for hospital environment.
<5% Un for 0.5
Voltage dips. Brief 0.5 cycles. If the device user
cycles. 40% Un
disruptions and 40% Un for 5 requires continued
for 5 cycles.
variations in voltage cycles. 70% operation during
70% Un for 25
on power supply input Un for 25 power outages and
cycles. <5% Un
lines. IEC 61000-4-11 cycles. <5% voltage dips, the
for 5 s
Un for 5 s device shall be
powered by an
uninterrupted power
supply or battery.

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IEC 60601-1-2 Compliance Electromagnetic

Immunity test
test level level environment
The magnetic fields at
Magnetic field at mains frequency shall
mains frequency have the same levels
3 A/m 3 A/m
(50/60Hz). IEC 61000- as a typical
4-8 commercial or
hospital environment.
3 Vrms
RF conducted IEC from 150kHz to
61000-4-6 80 MHz 3 Vrms
(1)
RF radiated IEC 61000- 3 V/m 3 V/m
4-3 from 80 MHz to
2.5 GHz
(1) Portable and mobile RF communication equipment shall be used no

closer to any part of the device, including cables, than the
recommended separation distance (d) calculated from the equation
applicable to the frequency of the transmitter.
d=1.167*sqrt (P)
d=1.167*sqrt (P) 80 MHz to 800 MHz
d=2.333*sqrt (P) 800 MHz to 2.5 GHz
P: maximum output power rating of the transmitter in watts (W),
according to the transmitter Manufacturer.
d: recommended distance in metres (m) at which the portable radio
frequency (RF) devices can be used.
The field strength emitted by fixed RF transmitters, as determined by
an electromagnetic site survey, shall be less than the compliance level
in each frequency range. Interference may occur in the vicinity of
equipment marked with the following symbol:

(Un) is the AC mains voltage prior to application of the test level.
At 80 MHz and 800 MHz, the higher frequency range applies. The
electromagnetic environment exposed may not apply in all
situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

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3 DEVICE DESCRIPTION
3.1 SUPPLY DESCRIPTION
Fig. 5 - Supply description
Optional: accessory not provided with the basic supply.
For the list of accessories and available models, contact the

Manufacturer or local Distributor.

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Pos Name Description

A Chin rest with Optional Adjustable height. Adjustable distance
adjustable chin between chin and forehead. Adjustable
cup chin cup
B Wheel cover Protection against accidental crushing of
fingers.
C Power supply unit A cable is provided with the power supply
unit.
D Diffusion filter To be magnetically applied to the device
for the analysis of the tear lipid layer
pattern.
E Sirius+ Device Comprised by a shooting unit equipped
with one or more micro video cameras
for image acquisition. USB cable
compatible with the device for
connection between the power supply
unit and computer.
F Application Application software for image
software acquisition and device management.
G Dust cover Place on the device when not in use to
protect it from dust.
H Hexagon wrench
with screws
I Package of chin Papers to be placed on the chin cup of
cup papers the chinrest.
J Ophthalmic table Optional Table top with one or two columns and
electronic adjustment of height. Drawer
and auxiliary sockets with cable guide.
K Calibration tool 8 mm radius calibration sphere.
L Isolation Optional 230V/230V for the use of the non-
transformer electromedical devices in the patient
area.
M Kit of additional Yellow filter for Fluorescein examination
lenses + negative lens for Meibography.

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3.1.1 SIRIUS+ DEVICE
Fig. 6 - Sirius+ Device
Pos Description
A Sirius+ Device
B Joystick
C Device locking knob
D Cogged wheels
E Connection cable between device and computer
F Connector between device and power supply unit
G Shooting channel

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3.1.2 POWER SUPPLY UNIT
Fig. 7 - Power supply unit
Pos Description
A Data plate
B Power supply unit
C Power supply status control light
D ON/OFF switch
E Device out connector
F Power grid connector
G Power supply cable from power grid
H Device power supply cable

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3.1.3 CHIN REST
Fig. 8 - Chinrest
Pos Description
A Chinrest support (*)
B Handle
C Chin cup adjustment knob
D Adjustable chin cup
E Forehead rest
F Chinrest structure
(*) The chinrest support may vary depending on the table top where
the chinrest will be installed.

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3.1.4 OPHTHALMIC TABLE

Different table models are available based on the customer's choice.
The table is composed of a table top on which the cogged guides for
the device compartment are installed. The table has one or two
motorised telescopic columns that permit the height adjustment of the
table top.
Fig. 9 - One-column table
Read the instructions for use of the ophthalmic table.
3.1.5 PERSONAL COMPUTER

The device shall be used in combination with a PC and the Phoenix
application software.
Minimum system requirements
- PC: 4 GB RAM - 1 GB RAM Video Card (not shared) resolution 1280
x 960 pixels or higher
- Operating system: Windows 7 (32/64 bit), Windows 8 (64 bit) and
Windows 10 (64 bit).
Read the instructions for use of the application software.

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Fig. 10 - Personal Computer
The PC shall comply with standard IEC 60950-1 Information

technology equipment - Safety - Part 1: General requirements.
If the PC is installed in the patient area, it is necessary to install an
isolation transformer that complies with standard IEC 60601-1:2005
+ A1:2012- "Electromedical equipment - Part 1: General
requirements for basic safety and essential performance".
It is possible to connect other accessories to the PC (printer, modem,
scanner, etc.) through the analogue or digital interfaces.
Accessories (printer, modem, scanner, etc.) shall be installed outside
the patient area.
The accessories shall comply with standard IEC 60950-1 Information
technology equipment - Safety - Part 1: General requirements.
If the accessories are installed in the patient area, it is necessary to
install an isolation transformer that complies with standard IEC
60601-1:2005 + A1:2012- "Electromedical equipment - Part 1:
General requirements for basic safety and essential performance".

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3.2 TECHNICAL DATA

Data transfer USB 3.0
External power supply unit 24 Vcc
Mains power In: 100-240 Vac - 50/60 Hz - 0.9-0.5 A
Out: 24 Vdc - 40 W
Network cable with C14 socket
Dimensions (Height x Length x Depth) 515 x 315 x 255 mm
Weight 7 kg
Chinrest stroke 70 mm ±1
Minimum height of the chin cup from
24 cm
the work surface
Base movement (x, y, z) 105 x 110 x 30 mm
Working distance 74 mm
Light sources
Placido Disk LED @400 - 700 nm
Scheimpflug LED @475 nm UV-free
Pupillography LED @940 nm
Lighting for Fluorescein examination LED @470 nm UV-free
Auxiliary lighting LED @400 - 700 nm

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Topography
Placido Disk 22 rings
From 42032 to 151232 (anterior surface)
Measured points
From 36400 to 145600 (posterior surface)
Topographic covering ø 12 mm
Class A complying with standard UNI EN ISO
Measurement accuracy
19980-2012
Accessories
Light diffusion filter for auxiliary illumination,
Light diffusing filter
with magnetic lock
Yellow barrier filter, with magnetic lock 530 nm filter
Additional lens, with magnetic lock Lens -6D
Calibration tool Calibration tool (8 mm
radius)

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4 DEVICE USE
4.1 HOW TO INSTALL THE DEVICE
CAUTION
Danger of falling device. The table shall be installed on a horizontal
and stable surface.
1 Place the ophthalmic table in the room. The table shall be
lifted by two people.
2 If present, fasten the table wheels. Lower the brake lever.
3 Place the power supply unit under the table top. Screw the
screws into the four holes.
Fig. 11 - Table placement Fig. 12 - Power supply unit placement

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4 Place the device on the table top and correctly align the
cogged wheels on the cogged guides.
5 Fasten the two wheel covers to the cogged guides on the table
top.
Fig. 13 - Placement of the device Fig. 14 - Placement of wheel covers
6 Install the chinrest. Beneath the table top, there are two
screws to fasten the chinrest support to the table top.
The chinrest shall be installed so that the eye-level indicator (1) is

placed at a height of 380 mm from the table top.
Fig. 15 - Placement of the chinrest Fig. 16 – Correct height of the eye-level indicator

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7 If the eye-level indicator does not reach the required height,

adjust the chinrest.
8 Loosen the 4 locking grub screws placed on the chinrest
support.
9 Slide the chinrest rods until the required height of 380 mm is
reached. Tighten the previously loosened locking grub screws.
The chinrest rods shall be adjusted upwards by no more than 15 mm.
Fig. 17 – Loosening the chinrest grub screws Fig. 18 – Maximum height for rod adjustment
10 Carry out the electrical connections between the different

components.

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4.2 HOW TO CONNECT THE DEVICE
Fig. 19 - Device connection
Pos Name
A 3.0 USB connection cable between device and PC
B Power supply cable to connect the electric table to the power supply unit
C Connection cable between power supply unit and device
To connect the table base to the power grid, read the instructions for
use of the table or ophthalmic unit.

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4.3 HOW TO ARRANGE THE ELECTRIC CABLES

CAUTION
Danger of falling device. Do not leave loose cables which may
represent an obstacle or danger for the patient or operator.
CAUTION
Danger of stumbling and falling. Do not leave the power or
connection cables loose in places where people may walk.
CAUTION
Risk of electric shock. Do not leave the power supply cables in
contact with sharp edges or cutting parts. Always collect and fasten
the power supply cables.
It is forbidden to use any extension cable not authorised by the

device Manufacturer.
For the proper placement of electrical cables and connection to the

lifting column, read the instructions for use of the ophthalmic tables
or ophthalmic units. The instruction manual can also be downloaded
from the website www.csoitalia.it.
The power socket on the lower part of the column of the ophthalmic
table is used to connect to the power grid. One of the power sockets
on the upper part of the lifting column is used for the device's power
supply unit.

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4.4 HOW TO TURN ON THE DEVICE
Read the instructions for use before using the application software.
1 Switch the power switch of the power supply unit to ON.

2 Turn on the PC.
3 Launch the Phoenix application software.
4 Wait until the main screen of the application software is
displayed.
5 If this is the first time you’re powering up the device, or after a
long period of non-use, calibration shall be performed. Follow
the instructions given in paragraph “How to perform device
calibration” on page 37.
4.4.1 HOW TO PERFORM DEVICE CALIBRATION
Calibration shall be performed when powering up the device for the
first time or after a long period of non-use.
The procedure should be carried out in a dark room to simulate the
environmental conditions of a standard acquisition procedure.
Follow the instructions for calibrating the Sirius+ device provided in

the Phoenix application software handbook.
Close attention shall be paid while performing the procedure. It is

important to check device stability before starting with the
procedure.
calibration is essential to obtaining precise measurements.
1 Ensure the calibration tool is clean and undamaged. If needed,

clean it using a soft cloth.
Do not use solvents or diluents to clean the calibration tool.

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2 Place the calibration tool on the chinrest.

3 Make sure the sphere is aligned with the shooting channel.
Fig. 20 - Placement of the calibration tool on Fig. 21 – Alignment of the calibration tool with
the chinrest the device
4 Launch the Phoenix application software.

5 Click on the device icon.
6 Click on the calibration button.
7 A window will appear on-screen, displaying the calibration
procedure. Carefully follow the instructions provided.
8 Align the red cross with the centre of the Placido rings
reflected on the sphere (8 mm radius).
9 Place the device at the correct distance from the sphere. The
correct distance is such that the white arc, corresponding to
the reflection of the blue slit on the sphere surface, touches
the red horizontal line displayed on the upper part of the
screen.
10 Fasten the device by using the device locking knob on its base.
11 Carry out image acquisition of the sphere visible on the
calibration tool (sphere radius 8 mm).
12 If the calibration procedure has been performed correctly, a
confirmation message will appear on-screen.
13 If not, repeat the entire calibration procedure.

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14 After performing calibration, an examination should be carried

out using the calibration tool (8 mm sphere radius) in order to
check proper calibration of the device.
15 Click on the button NEW PATIENT, enter their personal data,
then confirm and select the CORNEAL TOPOGRAPHY
examination.
16 After acquiring the image, press the EXIT button and process
the acquired examination.
17 On the SETTINGS panel, select the unit of measurement for
curvature in millimetres.
18 Verify that the value corresponds to that of the reference
sphere on the anterior tangential curvature map.
The radius measured on the anterior tangential curvature map must
be equal to 8 ± 0.03 mm.
19 If the calculated measures are not considered reliable, repeat
the entire calibration procedure.
If the device is not properly calibrated, repeat the calibration

procedure.
4.4.2 HOW TO CREATE A NEW PATIENT

1 Click on NEW PATIENT and enter their personal data. If the
patient is already present in the database, you can
automatically search for their surname by typing it into the
command prompt.
2 A new examination will be created automatically.
3 Select the examination to be performed.
4 The image acquisition screen will open. Now it will be possible
to proceed with the image acquisition.
4.4.3 HOW TO CREATE A NEW EXAMINATION

1 Click on the button NEW EXAMINATION.
2 Select the examination to be performed.
3 The image acquisition screen will open. Now it will be possible
to proceed with the image acquisition.

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4.5 HOW TO ADJUST THE CHIN CUP

1 Ask the patient to take a seat.
2 Move the chin cup left or right. The chosen position will
determine the position of the eye to be examined.
Fig. 22 - Adjustment of the chin cup
Fig. 23 – Chin cup positioning for left eye Fig. 24 – Chin cup positioning for right eye

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3 Show the patient how to position their face against the chin
cup and forehead rest
4 Check the eye is correctly positioned in relation to the shooting
channel.
Fig. 25 - Patient position on the chinrest

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5 Raise or lower the chin cup by rotating the knob.

6 Begin acquiring images as directed in section “How to acquire
an image” on page 43.
Fig. 26 - Knob rotation Fig. 27 - Chin cup placement
7 At the end of the acquisition procedure, ask the patient to lift

their face from the chin cup and forehead rest.
8 Move the chin cup in the opposite direction to that chosen
before.
9 Show the patient how to position their face against the chin
cup and forehead rest
10 Check the eye to be examined is correctly positioned in
relation to the shooting channel.
11 Begin acquiring images as directed in section “How to acquire
an image” on page 43.

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4.6 HOW TO ACQUIRE AN IMAGE

1 Rotate the joystick and align the device with the patient's eye.
2 Move the device towards the eye. Keep the reflection of the
corneal vertex centred in both images.
3 Perform small movements with the joystick for the best image
alignment.
Fig. 28 - Placement of the device Fig. 29 - Distance from the patient
4 Press the joystick button to acquire the image. The image will
be saved in the gallery.
5 Double click on the acquired image to process and visualise it
on the computer screen.
Fig. 30 - Image acquisition
Refer to the instructions for use of the application software for the
management of images in the database.

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4.7 HOW TO REPLACE CHIN CUP PAPERS

At the end of each examination, always remove the chin cup paper
to ensure a new and hygienic one for the next patient.
This device is provided with a package of chin cup papers. When you
use the last paper, substitute the package.
1 Extract the two plastic rivets
2 Insert the new package of chin cup papers
3 Insert the plastic rivets in the holes of the package and in the
holes of the chin cup.
Fig. 31 - Changing the chin cup papers
To order a replacement, read the code indicated on the list of spare

parts and accessories page 50.

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4.8 HOW TO TURN OFF THE DEVICE

CAUTION
Do not turn off the computer and do not disconnect the connection
cable between the computer and the device when the program is in
use.
1 Immobilise the device. Turn the locking knob.

2 Exit the images management program. Turn off the computer.
3 Switch the power switch of the power supply unit to OFF.
4 Place the dust cover on the device to prevent dust from
accumulating on the device.
Fig. 32 - Blocking the device

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5 ORDINARY MAINTENANCE
5.1 SAFETY WARNINGS
DANGER
Danger of electric shock. Unplug the power supply cable from the
power socket before disinfecting or cleaning the device and before
any maintenance operation.
CAUTION
The device does not contain any part requiring user intervention.
Do not remove any part of the device.
It is forbidden to carry out any maintenance operation on the device

not mentioned in the instructions for use.
In the case of damage or malfunction or for any maintenance

operations not mentioned in the instructions for use, it is necessary
to contact an authorised Service Centre or the device Manufacturer.
5.2 CLEANING AND DISINFECTION
CAUTION
Carefully follow the instructions for cleaning and disinfection
described in this manual, in order to avoid any damage to the
device and accessories.
CAUTION
A correct cleaning and disinfection procedure, together with
appropriate operating procedures, is essential to preventing the
spread of infections or cross contamination.
CAUTION
Danger of material damage. Do not use spray products.
Do not use excessively wet cloths, as they may drip.
If needed, use a damp and well wrung out cloth.
Make sure no liquid penetrates into the device.

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Cleaning and disinfection procedures shall be routinely carried out.
Device parts that do not come into direct contact with the patient
shall be cleaned at least once a day.
Device parts that do come into direct contact with the patient shall
be thoroughly cleaned and disinfected after each use.
This section describes the procedures to be carried out during use and
maintenance in order to ensure proper cleaning and disinfection of the
device and its accessories.
5.2.1 RECOMMENDED PRODUCTS FOR CLEANING AND DISINFECTION
CAUTION
Danger of material damage. Do not use solvents, acidic or basic
solutions (pH <4,5 or >8,0), abrasive or caustic substances, chlorine-
based and chlorine-derived products.
The Manufacturer is not liable for any damage caused by using
disinfectant products not indicated in this manual.
The choice of the most suitable product and procedures for the
cleaning and disinfection of the device shall take into account both the
sensitivity of the device to specific substances and the product’s
effectiveness.
For cleaning and disinfection procedures, use products approved by
the FDA or CE for medical devices or medical-surgical devices.
Abide by the products listed below, divided by category:
Detergents Use polyenzymatic solutions or neutral
surfactant-based solutions.
Disinfectants and Use products for disinfecting surfaces
decontaminating (containing or not containing aldehyde)
products or formaldehyde-free surface
disinfectants (i.e. Kohrsolin FF).
Alternatively, you may use ethyl alcohol,
70% v/v alcohol or isopropyl alcohol.

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For information about the use of the chosen product, follow the
instructions provided by the manufacturer.
5.2.2 CLASSIFICATION OF THE CRITICALITY OF THE DEVICE
CAUTION
The device supplied is not sterile and shall not be sterilised prior to
use.
This device is classified as “non-critical” since it is only used on intact

skin and therefore has a low infectious risk.
For devices classified as non-critical, regular cleaning or low-level
disinfection is sufficient.
However, when the patient’s condition is transmissible by direct
contact or in the case of accidental exposure to body fluids, the device
shall be disinfected with a higher-level disinfectant after cleaning.
5.2.3 DEVICE CLEANING
CAUTION
Carefully follow the cleaning instructions described in this section
in order to avoid any damage to the device and its accessories.
CAUTION
Danger of material damage. Clean using a non-abrasive cloth to
avoid damaging the surface.
The device shall be regularly cleaned.
The device is provided with a cover whose function is to protect it

from dust, especially during periods of non-use.
Clean the outer parts of the device using a damp, non-abrasive cloth
and a rinse-free cleaning solution.
For more information about suitable cleansing products, read section

“Recommended products for cleaning and disinfection” on page 47.

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5.2.4 CLEANING THE APPLIED PARTS
CAUTION
Danger of material damage. Only use detergent and disinfectant
products specifically approved for medical devices or medical-
surgical devices.
Applied parts that come into direct contact with the patient during
the examination shall be thoroughly cleaned after each use with a
disinfectant approved for the purpose.
1 Turn off the device and unplug it from the power socket.
2 Clean the applied parts using products suitable for surface
disinfection (they may contain aldehyde).
Alternatively, use a non-abrasive cloth soaked in a solution of
water, ethyl alcohol (70% maximum) or isopropyl alcohol.
For more information about suitable cleansing products, read section

“Recommended products for cleaning and disinfection” on page 47.
5.2.5 CLEANING THE OPTICAL COMPONENTS

CAUTION
Danger of material damage. The device is equipped with optical
components. The optical components of the device are precision-
and pressure-sensitive parts. Clean using a non-abrasive cloth to
avoid damaging the surface.
Clean the optical components carefully using a dry, non-abrasive, lint-

free cloth.
5.3 DEVICE CALIBRATION

Perform device calibration periodically in order to ensure accurate
measurements. Follow the calibration instructions given in paragraph
“How to perform device calibration” on page 37.

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5.4 SPARE PARTS AND ACCESSORIES LIST

Code Description
30010071D3F Power supply cable
Isolation transformer 230V/230V. 800 VA (maximum
10101300
load) power supply cable
4014020 Package of chin cup papers (50 pieces)
4013095 Dust cover
Electric support with one column for table top (230
10070144
V, 50 Hz)
33071095 Power supply cable for electric support (95 cm)
PSP2402 input 100-240 V AC 50/60 Hz max 0.9 A
103103900
output 24 VDC 2 A
100130201 Calibration tool
100130700 Chin rest with adjustable chin cup
963107100 Kit with additional lenses (yellow filter for
Fluorescein examination + negative lens for
Meibography)
103107105 Diffusion filter
For spare parts or accessories not included in the list, ask the
Manufacturer or local Dealer.

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5.5 TROUBLESHOOTING
Issue Cause Solution Note
If the device is
powered
through the
table's power
Connect the power
supply, check
The power supply supply cable of the
The device the
cable is not connected device to the power
does not connection of
to the power supply supply unit. Press
switch ON the table to
unit the device's ON
the electrical
button.
line. Check the
functioning of
the table
fuses.
Connect the power
supply cable to the Ensure the
The power supply
power supply unit. room's
The PC does cable is not connected
Switch the button electrical line
not start to the power supply
of the power supply works
unit
unit to ON. Replace properly.
the PC.
Ensure the
Replace the Hard new PC
PC operating Hard Disk failure.
Disk. Reinstall the conforms to
system does Corrupted operating
operating system. the minimum
not start system.
Replace the PC. requirements
of the device.

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Hard Disk failure. The Contact the
Replace the Hard
anti-virus software Technical
Disk. Check the anti-
impedes the launching Assistance.
virus software
The Phoenix of the Phoenix Installation of
settings. Reinstall
application application software. the Phoenix
the operating
software does Corrupted operating application
system. Reinstall
not start system. The Phoenix software
the Phoenix
application software requires
application
does not work administrator
software.
properly. privileges.
Unplug the
The connection cable connection cable
between the device between device and
and PC does not work PC and plug it in Installation of
The Phoenix properly. The anti- again. Replace the the Phoenix
application virus software connection cable application
software does interferes with the between the device software
not work drivers of the Phoenix and PC. Uninstall requires
properly application software. the anti-virus administrator
The Phoenix software. Reinstall privileges.
application software is the Phoenix
installed as local user application
software.
Check that the
mouse connection
Connection cable with
cable is properly
the PC disconnected. Check whether
inserted into the
The power switch of there are any
USB port. Turn on
The PC mouse the mouse is switched device
the mouse by
does not work to OFF. The mouse conflicts in the
switching the power
batteries are running PC control
switch to ON.
low (only for wireless panel.
Replace the mouse
mouse)
batteries (only for
wireless mouse).

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Check that the

keyboard
connection cable is
Connection cable with
properly inserted
the PC disconnected. Check whether
into the USB port.
The power switch of there are any
The PC Turn on the
the keyboard is device
keyboard keyboard by
switched to OFF. The conflicts in the
does not work switching the power
keyboard batteries are PC control
switch to ON.
running low (only for panel.
Replace the
wireless keyboard)
keyboard batteries
(only for wireless
keyboard).
Check that the

correct path to the
“database.db3” file
is specified on the
The database is not database
Regularly
The images connected to the configuration
check the
can't be saved Phoenix application screen. Refresh the
connection to
in the software. No internet connection to the
the data
database connection. The USB database file. Check
network.
cable does not work whether the
internet connection
is functioning.
Replace the USB
cable.

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Ask the patient to

keep their eyes
The patient moved or
Failed image open, look at the
closed their eyes
acquisition fixation light and
during the acquisition
not move their
eyes.
Poor image The tear film is not

Ask the patient to
quality from well distributed on the
close and open their
the Placido cornea surface (dry
eyes.
disk eyes)
Unfocused Make sure the

Dust or grease on the Clean the optical
image from patient does
optical parts of the parts of the device
the Placido not touch the
device with a soft cloth.
disk optical parts.
The joystick's plastic Before

Remove the
Device protection was not beginning the
joystick's plastic
movement removed from the examination,
protection from the
difficulties base during check that the
base. Loosen the
(ahead, back, installation. Device device
device blocking
left, right) blocking knob is blocking knob
knob.
fastened is loosened.

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Via degli Stagnacci 12/E | 50018 Scandicci (FI) | ITALY

Phone: +39 055 722191 | Fax: +39 055 721557
[email protected] | www.csoitalia.it
Sirius+ | IFU327EN02.04 - 11/2022

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COSTRUZIONE STRUMENTI OFTALMICI

Via degli Stagnacci 12/E | 50018 Scandicci (FI) | ITALY

This document is the property of C.S.O. SRL.

5 ORDINARY MAINTENANCE ...................................................................... 46

This document is the property of C.S.O. SRL.

Danger of electric shock

Read the instructions for use

Note. Useful information for the user

General prohibition sign

CE Marking (Directive 93/42/EEC)

This document is the property of C.S.O. SRL.

Waste disposal in compliance with Directives 2012/19/EU (WEEE)

1.1.1 DEVICE SYMBOLS

Type B applied part

1.2 GENERAL WARNINGS

It is forbidden to reproduce, totally or partially, texts or images

This document is the property of C.S.O. SRL.

The Manufacturer reserves the right to modify the contents of the

1.3 NORMATIVE REFERENCES

This document is the property of C.S.O. SRL.

This document is the property of C.S.O. SRL.

- the wearing out and/or deterioration of parts due to normal use

The client will not be refunded for damage caused by device

1.5 MANUFACTURER IDENTIFICATION

This document is the property of C.S.O. SRL.

This document is the property of C.S.O. SRL.

It is forbidden to carry out any technical operation on the device that

It is forbidden to place the device in humid, dusty places or

It is forbidden to use any extension cable not authorised by the

It is forbidden to use the device outdoors.

This document is the property of C.S.O. SRL.

2.2 DEVICE IDENTIFICATION

Fig. 1 - Data plate position

Fig. 2 - Device data plate

This document is the property of C.S.O. SRL.

2.2.3 POWER SUPPLY UNIT DATA PLATE

Fig. 3 - PSP2402 power supply unit data plate

2.3 INTENDED USE

This document is the property of C.S.O. SRL.

An additional negative lens is provided with the device. Magnetically

Analysis of the tear film

This document is the property of C.S.O. SRL.

This document is the property of C.S.O. SRL.

This document is the property of C.S.O. SRL.

- Advanced altimetry and Zernike summary

For system requirements, read section "Personal Computer” on

This document is the property of C.S.O. SRL.

The device shall only be used by specialist practitioners and

Fig. 4 - Patient area

2.4 MEDICAL DEVICE CLASSIFICATION

This document is the property of C.S.O. SRL.

2.5 ELECTROMEDICAL DEVICE CLASSIFICATION

2.6 ENVIRONMENTAL CONDITIONS

This document is the property of C.S.O. SRL.

2.7 DISPOSAL AT THE END OF THE USEFUL LIFE

This document is the property of C.S.O. SRL.

- in the event that a new device is purchased from the same

This document is the property of C.S.O. SRL.

2.8 MANUFACTURER DECLARATIONS

The device uses radio frequency