CSO sirius+ User manual

INSTRUCTIONS FOR USE
sirius+
COSTRUZIONE STRUMENTI OFTALMICI
1/174
EN
COSTRUZIONE STRUMENTI OFTALMICI
phone: [phone] | fax: [phone]
[email protected] | www.csoitalia.it
0051
Corneal Topograph/Tomograph
IFU327EN00 - 01/2021

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INSTRUCTIONS FOR USE
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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 Community directives ........................................................................................... 5
1.3.2 Technical standards.............................................................................................. 5
1.3.3 Quality management systems 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 Medical Devices List ..................................................... 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 DEVICES CLASSIFICATION ........................................................................ 16
2.5 MEDICAL ELECTRICAL DEVICES 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 Device sirius+...................................................................................................... 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............................................................................................. 29
3.2 TECHNICAL DATA .............................................................................................. 30
4DEVICE USE ............................................................................................. 32
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 32
4.2 HOW TO CONNECT THE DEVICE............................................................................. 37
4.3 HOW TO PLACE ELECTRIC CABLES .......................................................................... 38
4.4 HOW TO TURN ON THE DEVICE ............................................................................. 39
4.4.1How to perform device calibration ..................................................................... 39
4.4.2 How to create a new patient .............................................................................. 41
4.4.3 How to create a new examination...................................................................... 41
4.5 HOW TO ADJUST THE CHIN CUP ............................................................................ 42
4.6 HOW TO CAPTURE THE IMAGE.............................................................................. 45
4.7 HOW TO REPLACE CHIN CUP PAPERS ...................................................................... 46

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4.8 HOW TO TURN OFF THE DEVICE............................................................................ 47
5ORDINARY MAINTENANCE...................................................................... 48
5.1 SAFETY WARNINGS ........................................................................................... 48
5.2 CLEANING AND DISINFECTION.............................................................................. 48
5.2.1 Recommended products for cleaning and disinfection ....................................... 49
5.2.2 Classification of the device for hygiene and safety............................................. 50
5.2.3 Device cleaning .................................................................................................. 51
5.2.4 Cleaning the applied parts.................................................................................. 52
5.2.5 Cleaning the optical components ....................................................................... 52
5.3 DEVICE CALIBRATION ......................................................................................... 52
5.4 SPARE PARTS AND ACCESSORIES LIST ..................................................................... 53
5.5 TROUBLESHOOTING .......................................................................................... 54

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1INTRODUCTION
The device is the result of a long research period, conducted by
experts to give the product technical innovation, quality and design.
The device can be easily used thanks to the guided manual capture
and the electronic control of all the functions of the device.
1.1 SYMBOLS
Within the instructions for use, on the package or on the device, there
can be the following symbols:
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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Waste disposal in compliance with the Directive 2012/19/EU
(WEEE), and 2011/65/EU (RoHS II)
1.1.1 DEVICE SYMBOLS
Symbol
Meaning
Type B applied part
Class II device
1.2 GENERAL WARNINGS
THESE INSTRUCTIONS FOR USE REFER TO THE DEVICE SIRIUS+
("DEVICE" FROM NOW ON).
THE ORIGINAL TEXT IS IN ITALIAN.
Before using the device or if you don't use it since a long time, read
these instructions carefully. Read the instructions given in the
instruction manual and reported on the device.
Keep this manual close by for future consultation. If you should
decide to sell this appliance to other people, remember to also
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 product when this is sent back to an Authorized Service Centre.
Verify the presence of damage signs on the device caused by the
transport/storage, before using the device.

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It is forbidden to reproduce, totally or partially, texts or images
contained in these instructions for use without the written
authorization of the Manufacturer.
The Manufacturer reserves himself the right to modify the contents
of the instructions for use, without notice.
1.3 NORMATIVE REFERENCES
1.3.1 COMMUNITY DIRECTIVES
- Directive 93/42/EEC and subsequent modifications and
integrations concerning medical devices
- Directive 2012/19/EU on waste 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
topographs
1.3.3 QUALITY MANAGEMENT SYSTEMS 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 device conformity to the
Community directive 93/42/EEC as amended by the 2007/47/EC for:
- features
- safety and reliability
- CE marking
The Manufacturer refuses any responsibility for:
- installation and activation not activated in conformity to the
indications and the precautions reported in the instructions for use
- use not in compliance with the instructions for use and 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 effectuated by expert, qualified,
trained and personnel authorized by the Manufacturer
- electrical system of the space where the device is installed not in
compliance with the technical standards, the laws and regulations
in effect in the country of installation of the device
- direct or indirect consequences or damages to objects or persons,
originating from the improper use of the device or erroneous
clinical analysis originating from its use
The Manufacturer guarantees the device for 24 months after invoicing.
The Warranty includes the substitution, at the Manufacturer's or an
Authorized Service Centre, of components and materials and the
relative labour. The shipping and transport fees are to be paid by the
client.
The warranty does not cover:
- repairs of faults originating from natural disasters, mechanical
shocks (fall, hit, etc), electrical system faults, negligence, improper
use, maintenance or reparations carried out with non-original
materials
- any other improper use or not intended by the Manufacturer
- damages caused by service lack or inefficiency, originating by
causes or circumstances out of the Manufacturers control

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- the parts subject to usage and/or deterioration originating from
the normal use and those that might be broken because of an
improper use or maintenance carried out by personnel non-
authorized by the Manufacturer.
To ask maintenance interventions or to have technical information
about the device, address to an Authorized Service Centre or directly
to the device Manufacturer.
The client will not be refunded for damages originating from the
device halt.
1.5 MANUFACTURER IDENTIFICATION
CSO S.r.l.
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
Electric shock danger. Do not let water fall on the device. Do not
immerse the device in water or other liquids.
DANGER
Electric shock danger. If the power cables are damaged, they must
be replaced in an Authorized Service Centre to prevent any risk.
DANGER
Electric shock danger. Unplug the power cable from the main
s
socket before disi
nfecting the device and before any maintenance
operation.
CAUTION
Do not use the device if visibly damaged. Periodically inspect the
device and the connection cables to verify if there are damage
signs.
CAUTION
Always keep the device out of the reach of children.
CAUTION
Danger of device falling down. Do not leave free cables which can
represent an obstacle or a danger for the patient or the operator.
CAUTION
Danger of stumbling and falling. Do not let the power cord or t
he
connection cables free in a place where people could walk.
CAUTION
Electric shock risk. Do not touch the power supply cables with wet
hands.

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CAUTION
Electric shock risk. Do not leave the power supply cables in contact
with sharp corners or objec
ts. Collect and attach always the power
supply cables.
CAUTION
If you notice a wired odour or smoke coming out of the device or if
it emanates heat, turn it off immediately. Do not keep using a
damaged product or a damaged part. Danger of injuries.
CAUTION
The electrical net must have a Residual-
Current Circuit Breaker
(IΔn=30mA) Thermal-
Magnetic 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 ou
t any technical operation on the device that
is not recalled or described in these instructions for use.
It is forbidden to place the device in humid, dusty places or
environments subject to sudden temperature and humidity
variations.
It is forbidden to use any extension cable not authorized by the
manufacturer.
It is forbidden to use the device outdoors.
The device does not generate and does not receive any
electromagnetic interference if it is 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 MEDICAL DEVICES LIST
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 - Power supply unit PSP2402 data plate
2.3 INTENDED USE
Sirius+ is a medical device used for diagnosis in ophthalmology. The
device combines optical reflection topography with Placido's disk to
the Sheimpflug tomography of the anterior segment.
The device has been designed for the capture and the elaboration of
25 images of the cornea section and of the 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.
Thanks to two video cameras, you can film "live" the cornea and the
anterior chamber of the eye and visualize them on the computer
screen.
In addition to the clinical diagnostic, the most common fields of
application are the 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 the photo-ablative surgery planning and the
follow-up.
On the basis of the pachymetry map and corneal elevation data, the
device allows the intrastromal rings system planning, for the
correction of refractive defects and some forms of keratoconus.

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Corneal topography
The device provides information on pachymetry, elevation, curvature
and refractive power of both corneal surfaces over a diameter of 12
mm.
Pupillography
The pupillography module is completely integrated with the
topography and allows to:
- follow the pupillometry measurement in scotopic light condition in
order to evaluate the maximal pupil extension and the optic zone
dimension that has to be set for a treatment.
- Perform the pupillometry measurement in scotopic light conditions
(0.04 lux).
- Perform the pupillometry measurement in mesopic light condition
(4 lux).
- Perform the pupillometry measurement in photopic light condition
(50 lux).
- Perform the dynamic pupillometry measurement, starting form
400 lux and turning off the luminous source so that the pupil
dilates to its maximal extension.
- Evaluate the pupillary decentralization with respect to the corneal
vertex for each of the conditions described above and the pupillary
centre deviation during the dilatation.
Meibography
The device allows to analyse the Meibomian glands in a non-invasive
method. The meibography is performed through the infrared
illumination which enhance the 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.

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Analysis of the tear film
The Placido's disk allows the advanced analysis of the tear film and the
evaluation of the NI-BUT (Non-Invasive Break-up Time).
Videokeratoscopy
Sirius+ has a white light source which aids with the capturing of colour
images or videos and a cobalt blue light source for the analysis of
corneal surface, fluorescein staining and rigid contact lenses fitting.
The accessory yellow filter, which is attached to the device
magnetically, enhances the visualization of the image when stained
with fluorescein.
The accessory negative lens supplied with the device increases the
magnification of the visual field allowing for the analysis of tear
meniscus height and conjunctival or limbar hyperemia.
The accessory diffuser filter supplied with the device, which is attached
to the Placido disk magnetically, allows for the analysis of the lipid
layer interference pattern.
Corneal aberrometry
The device allows for the analysis of the corneal aberrometry. It is
possible to select the anterior, posterior or total corneal contribution
for different diameters of the pupil. The OPD/WFE map and the visual
simulations (PSF, MTF and image convolution) can help understanding
and explaining the patient’s visual discomfort.
IOL calculation module
It is available an IOL calculation module based on Ray-Tracing
techniques which, regardless of the clinical status of the cornea,
provides the values of the spherical and toric power of the intraocular
lens. This allows the planning of the surgery for refractive defects by
means of intraocular lens implants.

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Glaucoma screening
The device allows the glaucoma screening and gives the measurement
of iridocorneal angles and corneal pachymetry. These values, and the
most common IOP correction formulas are useful to diagnose some
diseases which can be due to the conformation of the anterior
chamber.
Keratoconus screening
An efficient keratoconus screening system, clinically validated,
provides suggestions on the ectasia risk underlining the cases which
have a greater possibility of complications.
Module for contact lenses application.
The module for the application of contact lenses application allows to
perform the simulation of rigid contact lenses thanks to a wide
database of models and international manufacturers.
Dry Eye Report
The Dry Eye Report provides a general evaluation of the patient’s
clinical conditions, aimed at diagnosing tear film dysfunctions. The
evaluation is based on:
- Ocular Surface Disease Index (OSDI)
- Analysis of the redness of the eye
- Analysis of Meibomian glands
- Tear meniscus analysis
- NiBUT.
More features of the device with the application software
The device, with the application software allows:
- Guided manual capture
- Management of the patients' data and possibility to personalize
researches and statistics
- Advanced editing system of the rings which allows to modify the
position of the edges in order to provide a proper reconstruction
even on distorted surfaces.

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- Availability of the following maps: sagittal curvature map,
tangential curvature map, elevation, refractive power, Gaussian
curvature map, corneal thickness.
- Screens and summaries which allow to personalize the device
depending on the user:
- Four maps summary
- Single map screen
- Keratoconus summary
- Six maps summary
- Advanced altimetry and Zernike summary
- Corneal wavefront analysis with setting of the pupil, it
includes the maps of the most common aberrations
- Corneal wavefront analysis with summary of visual quality
referred to the anterior corneal face with PSF, Spot Diagram,
MTF and vision simulation for the analysed wavefront
- Autofit for the research of the best contact lens based on the
altimetric elevation measure of the cornea, on a database of more
than 50.000 lenses
- Possibility to personalize the contact lens and to simulate its
application
- Tools for the follow-up control with differential maps with 2 or 3
elements
- Tools for the follow-up control with comparison between 4
different maps
- A wide series of concise descriptors of the features of the cornea,
such as:
- Sim-K to simulate the measurement of an ophthalmoscope
with fixed targets (for the anterior surface)
- Principal corneal meridians in the zones of 3 mm, 5 mm and
7 mm
- flatter and steeper hemimeridians in the zones of 3 mm, 5
mm and 7 mm
- Peripheral degrees
- Pupil decentralization, pupil diameter, and corneal diameter
size

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- Keratorefractive indices calculated in the pupil area for an
evaluation of the patient's visual quality
- Keratoconus screening index for diagnosis and follow-up
- Dry Eye Report
For system requirements read paragraph "
Personal Computer” at
page 29.
The device must be only used by specialist practitioners and
operators (such as optometrists), within the limits of the law and the
regulations for the exercise of the profession.
Patient area: any volume in which intentional or unintentional
contact can occur between patient and parts of the system or
between patient and other persons touching parts of the system.
Fig 4 - Patient area
2.4 MEDICAL DEVICES CLASSIFICATION
Technical data
Value
Classification in compliance with the
attached IX to the Directive
93/42/EEC and subsequent
modifications
Class IIa

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2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION
Classification complying with the standard EN 60601-1:2005 + A1:2012
Technical data
Value
Type of protection against the direct
and indirect contacts
Class I
Applied parts
Type B
Protection degree against humidity
IP20 (no protection against liquid
infiltration)
Sterilization or disinfection method
This device can be disinfected
Protection degree in presence of
anaesthetics or inflammable
detergents
No protection
Electrical connection degree between
device and patient
Appliances with applied part on 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
Bumb
10g duration 6ms

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CAUTION
Danger of device damages. During transport and storage, the
device can be exposed to the environmental conditions for a
maximum period of 15 weeks, only if kept in the original packaging.
2.7 DISPOSAL AT THE END OF THE USEFUL LIFE
Instruction for disposal of product correctly according to European
Directive 2012/19/EU, and 2011/65/EU about the reduction of use
of dangerous substances in the electrical and electronic equipment,
as well as waste disposal.
At the end of its useful life, the device m
ust not be disposed of as
urban waste. The device can be delivered to the appropriate
separate waste collection centres set up by municipal
administrations or to retailers that offer this service. Separa
tely
disposing of an electrical device prevents possi
ble negative
consequences for the environment and health, caused by its
improper disposal, and lets the materials it is made of to be
recycled so as to achieve significant savings of energy and
resources. On the label of the device there is the symbol of t
he of
the crossed-out wheeled bin. The graphic symbol of the crossed-
out
wheeled bin, indicates the obligation to collect and dispose
separately the electrical and electronic equipment at the end of
their useful life.
The user has to consider the effects potentially dangerous for the
environment and the human health originating from an improper
disposal of the whole device or its parts.
In case the user wishes to dispose of the device used at the end of its
useful life, the Manufacturer facilitates the possibility of its reuse and
the recovery and recycling of the materials contained therein. This to
prevent the release of hazardous substances into the environment and
to promote conservation of natural resources. Before disposing of the
device, it is necessary to take into consideration the European and
national regulations that order what follows: