CSO sirius+ User manual

0051
EN
COSTRUZIONE STRUMENTI OFTALMICI
COSTRUZIONE STRUMENTI OFTALMICI
Via degli Stagnacci 12/E | 50018 Scandicci (FI) | ITALY
Phone: [phone] | Fax: [phone]
[e-mail] | www.csoitalia.it
Corneal Topographer/Tomograph
Sirius+
INSTRUCTIONS FOR USE
IFU327EN02.04 - 11/2022

Sirius+ | IFU327EN02.04 - 11/2022
INSTRUCTIONS FOR USE
This document is the property of C.S.O. SRL.
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1INTRODUCTION......................................................................................... 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
2SAFETY....................................................................................................... 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
3DEVICE 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
4DEVICE 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

INSTRUCTIONS FOR USE
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5ORDINARY 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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1INTRODUCTION
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: [phone] - fax [phone]
[email protected]
www.csoitalia.it

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2SAFETY
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=230
V) 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
modifications
Class IIa

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2.5 ELECTROMEDICAL DEVICE CLASSIFICATION
Classification based on the IEC 60601-1:2005 + A1:2012 technical
standard
Technical data
Value
Type of protection against direct and
indirect contacts
Class I
Applied parts
Type B
Degree of protection against humidity
IP20 (no protection against infiltration
by liquids)
Sterilisation or disinfection method
This device can be disinfected
Degree of protection in the presence
of anaesthetics or inflammable
detergents
No protection
Degree of electrical connection
between device and patient
Devices with part applied to the
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
Atmospheric pressure
700 hPa
1060 hPa
Relative humidity
10%
95%
Use
Temperature
+10°C
+35°C
Atmospheric pressure
800 hPa
1060 hPa
Relative humidity
30%
90%
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 electric
al 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 di
splays 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.