CSO POLARIS User manual

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IT
COSTRUZIONE STRUMENTI OFTALMICI
phone: [phone] | fax: [phone]
[email protected] | www.csoitalia.it
POLARIS
Advanced analysis of the tear lm
INSTRUCTIONS FOR USE

POLARIS | IFU312EN00
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
1.3.1Community 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 Device data plate................................................................................................ 10
2.3 INTENDED USE.................................................................................................. 10
2.4 MEDICAL DEVICES CLASSIFICATION ........................................................................ 14
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION ......................................................... 15
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 15
2.7 DISPOSAL AT THE END THE USEFUL LIFE................................................................... 16
2.8 MANUFACTURER DECLARATIONS .......................................................................... 18
2.8.1 Electromagnetic emissions ................................................................................. 18
3DEVICE DESCRIPTION .............................................................................. 22
3.1 PROVISION DESCRIPTION..................................................................................... 22
3.1.1 Accessory device Polaris ..................................................................................... 24
3.1.2 Tools kit .............................................................................................................. 25
3.2 TECHNICAL DATA .............................................................................................. 26
4DEVICE USE ............................................................................................. 27
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 27
4.2 HOW TO CONNECT THE DEVICE............................................................................. 30
4.3 HOW TO PLACE THE ELECTRIC CABLES..................................................................... 32
4.4 HOW TO INSERT THE FILM IN THE DEVICE LIGHTING HEAD............................................33
4.5 HOW TO TURN ON THE DEVICE ............................................................................. 33
4.6 ADJUST THE CHIN REST ....................................................................................... 34
4.7 HOW TO VISUALIZE THE IMAGE............................................................................. 36
4.8 HOW TO ANALYZE THE LIPID FILM.......................................................................... 37
4.9 HOW TO ANALYZE THE INFERIOR TEAR MENISCUS HEIGHT............................................37
4.10 HOW TO ANALYZE THE TEAR FILM STABILITY AND REGULARITY ...................................... 39
4.11 HOW TO ANALYZE THE CORNEAL SURFACE REGULARITY............................................... 40
4.12 HOW TO CAPTURE THE IMAGE.............................................................................. 41
4.13 HOW TO TURN OFF THE DEVICE ............................................................................ 41
5ORDINARY MAINTENANCE...................................................................... 43

INSTRUCTIONS FOR USE
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5.1 SAFETY WARNINGS ........................................................................................... 43
5.2 DEVICE CLEANING............................................................................................. 43
5.3 SPARE PARTS AND ACCESSORIES LIST ..................................................................... 44
5.4 TROUBLESHOOTING .......................................................................................... 44

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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 is an accessory for the slit lamp, it allows an accurate
analysis of the patient's tear film.
1.1 SYMBOLS
Within the instructions for use, on the package or on the device, there
can be the following symbols:
Symbol
Meaning
Caution
Warning, electricity
Read the instructions for use
General mandatory action sign
Note. Useful information for the user
General prohibition sign
Manufacturer
CE Marking (Directive 93/42/EEC)

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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 equipment
1.2 GENERAL WARNINGS
THESE INSTRUCTIONS FOR USE REFER TO THE ACCESSORY
DEVICE POLARIS ("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
instructions 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 result
ing from inadequate packaging of
the product when this is sent back to an Authorized Service Center.

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Before using the device check that there is no sign of damages due to
transport or an incorrect storage, that could compromise the correct
functioning of 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.
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 instruments.
- 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.
1.3.3 QUALITY MANAGEMENT SYSTEMS STANDARDS
- UNI CEI EN ISO 13845:2016 - 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 Center, of components and materials and the
relative labor. The shipping and transport fees are to be paid by the
client.
The warranty does not cover:
- reparations 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 Center 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]
[e-mail]
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 Center to prevent any risk.
DANGER
Electric shock danger. Unplug the power cable from the mains
socket before disinfecting the dev
ice 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 fall 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 the
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 objects. Collect and attach always the pow
er
supply cables.
CAUTION
If you notice a wired odor 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 out any technical operation on the devic
e that
is not recalled or described in the 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 DEVICE DATA PLATE
Fig 1 - Plate position
Pos
Description
A
Device data plate
Fig 2 - Device data plate
2.3 INTENDED USE
POLARIS is a device for the advanced analysis of the tear film. Itallows
to estimate the quality and quantity of the tear film. Through non-
invasive break up time test (NIBUT) it is possible to analyze its stability
and regularity. Others test allows to evaluate the corneal surface and
the lower tear meniscus.

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The device is an accessory for the slit lamp, composed of a light
source, which does not require the application of any substance on the
surface eye. The substance would adulterate the tear film composition
and the exam wouldn't be reliable.
The light source of the device is composed by a white LED light that
replaces the Slit Lamp illuminator. The light source of white light
prevents excessive tearing or evaporation of the tear film. Through the
Slit Lamp microscope the image projected by the device, reflected on
the patient's eye tear film is observed by the microscope.
The device can be perfectly integrated with the application software
Phoenix.
Lipid film quality and quantity
The device enables interferometric examination of the lipid layer of
the tear film.
Depending on the thickness and regularity of the lipid layer, this may
appear like any of the following: amorphous structure, marble
appearance, wavy appearance, yellow, brown, blue or reddish
interference fringes. The following picture shows an example of
interferometric images.

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Inferior tear meniscus
Most tears are collected in the inferior and superior tear meniscus. The
size of the tear meniscus formed on the eyelid borders provides, then,
useful information on the produced liquid volume.
The tear meniscus can be examined taking into account its height,
regularity and shape.
The luminous intensity of the device is calibrated so as not to cause
glare of the patient preventing reflex tearing.
Tear film stability and regularity
The device allows to evaluate the stability and the regularity of the
tears film, through the measurement of the non-invasive break up
time (NIBUT). The image reflected by the tear film surface enables to
observe and evaluate the regularity of the tear film on the patient's
eye surface and to measure the break up time (NIBUT).
The non-invasive break up time is the measurement, in seconds, of the
time between the last complete blinking and the appearance of the
film discontinuity on the tear film. The observed pre-rupture phase
indicates the tear film thinning time. These measurements can be
taken with or without contact lenses.
Corneal surface regularity
The device can also be used to assess the regularity of the corneal
surface. By inserting the specific grid inside the internal cylinder of the
device, a series of concentric rings is projected onto the cornea thus
performing a keratoscopy. A regular cornea will result in a reflected
image with a series of concentric rings, all at the same distance. Any
irregularities in the surface of the cornea will result in irregularities of
the reflected image. Closer rings correspond to areas of steeper curved
cornea, while more distance between rings correspond to flatter
cornea area.
The device must be used only by practitioners, within the limits of the
law and the regulations for the exercise of the profession.
The device can be used in combination with a PC and the application
software Phoenix.
System minimum requirements

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- PC: 4 GB RAM - Video Card 1 GB RAM (not shared) resolution 1024
x 768 pixels
- Operating system: Windows XP, Windows 7 and Windows 10
(32/64 bit).
Read the instructions for use of the application software.
The PC must be compliant to the norm 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 electrical supply compliant with the directive IEC 60601-
1:2005 + A1:2012- "Medical electrical 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 analogical or digital interfaces.
The accessories (printer, modem, scanner, etc) must be installed
outside the patient area.
The accessories must be compliant to the norm 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 electrical supply compliant with the directive IEC
60601-1:2005 + A1:2102 - "Medical electrical equipment -
Part 1:
General requirements for basic safety and essential performance".

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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 3 - Patient area
2.4 MEDICAL DEVICES CLASSIFICATION
Technical data
Value
Classification in compliance with the
attached IX to the Directive 93/42/EEC
and successive modifications
Class I

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2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION
Classification in compliance with the technical specification EN 60601-
1:2005 + A1:2012
Technical data
Value
Type of protection against the direct
and indirect contacts
Class II
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
anesthetics or inflammable detergents
No protection
Electrical connection degree between
device and patient
Appliances with part applied 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%

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Phase
Technical data
Min
Vibration
Sinusoidal
10 Hz to 500 Hz, 0.5g
Shock
30g duration 6ms
Bumb
10g duration 6ms
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 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
equipments, and waste disposal.
At the end of its useful life, the
device must not be disposed of as
urban waste. The device can be delivered to the appropriate
separate waste collection centers set up by municipal
administrations or to retailers that offer this service. Separately
disposing an electrical device prevents
possible 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 a significant savings of energy and
resources. On the label of the device there is the symbo
l of the 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.

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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 the
device, it is necessary to take into consideration the European and
national regulations that order what follows:
- not to dispose as urban waste but collect it separately and address
to a firm specialized in the disposal of electrical and electronic
equipment or to the local administration in charge for waste
collection.
- 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 of the new
device, the Distributor or Manufacturer are legally required to
collect the old device.
- if the user decides to dispose a used device, put on the market
after the 13th August 2005, the Distributor or the Manufacturer
have to collect it.
- the Manufacturer takes care, by joining a consortium for the
technological devices waste, of the treatment and the recycling of
the used device by paying its costs.
The Manufacturer is available to give the user all the information
about the dangerous substances contained in the device, an
d on the
recycling modalities of those substances and about the possibility of
a reuse of the used device.
Strict sanctions for transgressors are provided for by law.
For specific information about the disposal in other countries than
Italy, contact the 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
Radio frequency emission.
CISPR 11 Group 1
The device uses radio frequency energy
only for its inner functioning. The radio
frequency emissions of the device are
very low and should not cause
interferences with the near appliances.
Radio frequency emission.
CISPR 11 Class B
The device can be used in all the
environments, included the domestic
environment. The device can be
connected directly to a low tension
power supply net as there is in the
housing units.
Harmonic emissions. IEC
61000-3-2 Class A
The device can be used in all the
environments, included the domestic
environment. The device can be
connected directly to a low tension
power supply net as there is in the
housing units.
Limitation of voltage
changes, voltage
fluctuations and flicker.
IEC 61000-3-3
Compliant
The device can be used in all the
environments, included the domestic
environment. The device can be
connected directly to a low tension
power supply net as there is in the
housing units.