INSTRUCTIONS FOR USE

MS-39 | IFUMS-39EN00

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 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
2 SAFETY ....................................................................................................... 8
2.1 SAFETY WARNINGS .............................................................................................. 8
2.2 DEVICE IDENTIFICATION ...................................................................................... 10
2.2.1 Registration data in the Medical Devices Repertoire .......................................... 10
2.2.2 Device data plate................................................................................................ 10
2.2.3 Power suppliers data plate ................................................................................. 11
2.3 INTENDED USE .................................................................................................. 12
2.4 MEDICAL DEVICES CLASSIFICATION ........................................................................ 17
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION ......................................................... 18
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 18
2.7 DISPOSAL AT THE END THE USEFUL LIFE................................................................... 19
2.8 MANUFACTURER DECLARATIONS .......................................................................... 21
2.8.1 Electromagnetic emissions ................................................................................. 21
3 DEVICE DESCRIPTION .............................................................................. 24
3.1 PROVISION DESCRIPTION..................................................................................... 24
3.1.1 Device AS-OCT .................................................................................................... 26
3.1.2 Power supplier .................................................................................................... 27
3.1.3 Chin rest (optional) ............................................................................................. 28
3.1.4 Electric table (optional) ...................................................................................... 29
3.2 TECHNICAL DATA .............................................................................................. 29
4 DEVICE USE ............................................................................................. 31
4.1 HOW TO INSTALL THE DEVICE ............................................................................... 31
4.2 HOW TO CONNECT THE DEVICE ............................................................................. 33
4.3 HOW TO PLACE THE ELECTRIC CABLES ..................................................................... 34
4.4 HOW TO TURN ON THE DEVICE ............................................................................. 35
4.5 ADJUST THE CHIN REST ....................................................................................... 36
4.6 HOW TO CAPTURE THE IMAGE .............................................................................. 38
4.7 HOW TO CHANGE THE PAPER FOR CHIN CUP ............................................................ 40
4.8 HOW TO TURN OFF THE DEVICE ............................................................................ 41
5 ORDINARY MAINTENANCE ...................................................................... 42
5.1 SAFETY WARNINGS ............................................................................................ 42

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5.2 DEVICE CLEANING ............................................................................................. 42

5.3 SPARE PARTS AND ACCESSORIES LIST ..................................................................... 43
5.4 TROUBLESHOOTING .......................................................................................... 44

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1 INTRODUCTION
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 electrŽŶŝĐcontrol of all the functions of the device.
1.1 SYMBOLS
Within the information for use, on the package or on the device, there
can be the following symbols:

Symbol Meaning

Caution

tĂƌŶŝŶŐ͕ĞůĞĐƚƌŝĐŝƚLJ

ReĨĞƌƚŽŝŶƐƚƌƵĐƚŝŽŶŵĂŶƵĂůͬůŬůĞƚ

General ŵĂŶĚĂƚŽƌLJĂĐƚŝŽŶƐŝŐŶ

Note. Useful information for the user

General prohibition ƐŝŐŶ

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

dLJpe B ĂƉƉůŝĞĚƉĂƌƚ

Class II ĞƋƵŝƉŵĞŶƚ

1.2 GENERAL WARNINGS

THESE INFORMATION FOR USE REFER TO THE DEVICE AS-OCT
MODEL MS-39 ("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
carefully this information for use. Read the instructions given in the
information 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 Center.

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 and images

contained in this information for use without the written
authorization of the Manufacturer.

The Manufacturer reserves himself the right to modify the contents

of the information 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.
- UNI EN ISO 19980:2012 - Ophthalmic instruments - Corneal
topographers
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 information for use
- use not in compliance with the information for use and precautions
reported in the information 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 - Badia a Settimo (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
Electric shock danger. Don 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 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 fall. 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.

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CAUTION
Electric shock risk. Do not touch the power supply cables with wet
hands.

CAUTION
Electric shock risk. Do not leave the power supply cables in contact
with sharp corners or objects. Collect and attach always the power
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
;/ȴŶсϯϬŵͿdŚĞƌŵĂů-DĂŐŶĞƚŝĐŝƌĐƵŝƚƌĞĂŬĞƌ;sŶсϮϯϬsͿƚŽƉƌŽƚĞĐƚ
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 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.

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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.

2.2 DEVICE IDENTIFICATION

2.2.1 REGISTRATION DATA IN THE MEDICAL DEVICES REPERTOIRE
E;ŶĂƚŝŽŶĂůŵĞĚŝĐĂůĚĞǀŝĐĞƐĐůĂƐƐŝĨŝĐĂƚŝŽŶͿ
ZĞƉĞƌƚŽŝƌĞŶƵŵďĞƌ;ƉƌŽŐƌĞƐƐŝǀĞƐLJƐƚĞŵŶƵŵďĞƌĂƚƚƌŝďƵƚĞĚƚŽƚŚĞĚĞǀŝĐĞͿ
Market release date

The device registration data can be verified on the Ministero della

Salute website on this page:
Ministero della Salute - Ricerca dispositivi
2.2.2 DEVICE DATA PLATE

Fig 1 - Plates position

Pos Description
A Device data plate

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Fig 2 - Device data plate

2.2.3 POWER SUPPLIERS DATA PLATE

Fig 3 - Power supplier PSP2402 data plate

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2.3 INTENDED USE

AS-OCT model MS-39 is an electro-medical device used in the
Ophthalmological Diagnosis to perform the analysis of the anterior
segment of the eye. In a single structure, it combines corneal
topography with Placido’s disk and OCT-based anterior segment
tomography.
The device has been designed for the screening, the capture and
the eƉƌŽĐĞƐƐŝŶŐ of 25 clear sectional images, in high resolution
over a diameter of 16 mm.
The device provides pachymetry data, elevation, ĐƵƌǀĂƚƵƌĞ and
power information of both the faces of the cornea
Additional satellite exams allow an accurate pupil diameter
measurement in scotopic, mesopic, photopic conditions and in
dynamic mode and their integration with corneal map.
Based on the pachymetry map and corneal ĂůƚŝŵĞƚƌŝĐĞůĞǀĂƚŝŽŶdata,
the device allows the intrastromal rings system planning, for the
correction of refractive defects and some forms of keratoconus.
The device allows the glaucoma screening and gives the measurement
of irido-corneal angles and 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.
Corneal topography and tomography of the anterior segment
The device provides information on pachymetry, elevation, curvature
and dioptric power of both corneal surfaces over a diameter of 10 mm.
All biometric measurements of the anterior chamber are calculated
starting from 25 sections from the cornea over a diameter of 16 mm.
In addition to the clinical diagnostic, the most common fields of
application are the refractive and cataract surgery.

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Pupillography
The pupillography module is completely integrated with the
topography and allows to:
- Perform 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 condition
(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
center deviation during the dilatation.
- Apply the measurements enlisted above to the corneal wavefront
calculation and visualize the pupil in different conditions on the
topographic map.
Analysis of the tear film
The Placido's disk allows the advanced analysis of the ƚĞĂƌfilm and
the evaluation of the NI-BUT (Non Invasive Break-up Time).
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 corneal surgery
for refractive defects͕ either photoablative and by means of
intraocular lens implants.

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Corneal aberrometry
The device allows to perform 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.
BiometrLJof the crystalline
In order to more accurately determine the ELEP, and consequently to
refine the intra-ocular lens calculation, the device provides a capture
mode to measure the crystalline lens thickness, its distance from the
cornea and its equator.
Glaucoma screening
The device allows the glaucoma screening and gives the
measurement of irido-corneal angles AOD, d/^ 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 keratoconous screening system, clinically validated, based
on a self-learning system, provides suggestions on the risk
underlining the cases which have a greater possibility of complications.
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
personalizeresearches and statistics
- measurements and evaluations of the sagittal and tangential
curvature of the cornea, both for the anterior and posterior
surfaces.
- maps visualization: pachymetry, refractive power (anterior,
posterior and total), altimetric ĞůĞǀĂƚŝŽŶ (anterior and posterior)
and depth of the anterior chamber, epithelial map

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- maps summaries
- analysis of the anterior segment aberrations
- analysis of the differential maps
- advanced editing system of the rings which allows to modify the
position of the edges in order to provide a proper reconstruction
even on bended surfaces.
- availability of the following maps: sagittal curvature map,
tangential curvature map, altimetry, refractive power, Gaussian
curvature map
- screens and summaries which allow to personalize the device
depending on the user's necessities:
- 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 tho the anterior corneal face with PSF, Spot
Diagram, MTF and vision simulation for the analyzed
wavefront
- 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 ophtalmoscope
with fixed targets (for the anterior surface)
- principal corneal meridians in the zones of 3 mm, 5 mm and
7 mm
- flatter and more curve hemimeridians in the zones of 3 mm,
5 mm and 7 mm
- peripheral degrees

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- pupil decentralization, pupil diameter, and corneal diameter

size
- keratorefractive indices calculated in the pupil area foƌ an
evaluation of the patient's visual quality
- keratoconus screening index for diagnosis and follow-up
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 must be used in combination with a PC and the software
Phoenix.
System minimum requirements
- 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 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.

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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".

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
Class IIa
93/42/EEC and subsequent
modifications

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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
Class II
and indirect contacts
Applied parts Type B
IP20 (no protection against liquid
Protection degree against humidity
infiltration)
Sterilization or disinfection method This device can be disinfected
Protection degree in presence of
anesthetics or inflammable No protection
detergents
Electrical connection degree between Appliances with part applied on the
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
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%

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.

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2.7 DISPOSAL AT THE END THE USEFUL LIFE

Instruction for disposal of product correctly according to European
ŝƌĞĐƚŝǀĞϮϬϭϮͬϭϵͬh͕ĂŶĚϮϬϭϭͬϲϱͬhĂďŽƵƚƚŚĞƌĞĚƵĐƚŝŽŶŽĨƵƐĞ
of dangerous substances in the electrical and electronic equipment,
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 symbol 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.

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 the device 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.

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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 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, and 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 Supplier.

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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 inner functioning.
Radio frequency The radio frequency emissions of the
Group 1
emission. CISPR 11 device are very low and should not
cause interferences with the near
appliances .
The device can be used in all the
environments, included the domestic
Radio frequency environment. The device can be
Class B
emission. CISPR 11 connected directly to a low tension
power supply net as there is in the
housing units.
The device can be used in all the
environments, included the domestic
Harmonic emissions. IEC environment. The device can be
Class A
ϲϭϬϬϬ-3-2 connected directly to a low tension
power supply net as there is in the
housing units.
The device can be used in all the
Limitation of voltage environments, included the domestic
changes, voltage environment. The device can be
Compliant
fluctuations and flicker. connected directly to a low tension
IEϲϭϬϬϬ-3-3 power supply net as there is in the
housing units.

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/ϲϬϲϬϭ-1-2 Conformity
Immunity test Electromagnetic environment
test level level
Floors should be wood,
8kV contact. concrete or ceramic tile. If the
Electrostatic IEC 60601-
2/4/8/15 kV floors are covered with
discharge. IEC 1-2 Test
air. synthetic material the relative
ϲϭϬϬϬ-4-2 level
humidity should be at least
30%.
Portable and mobile RF
Radiated communication equipment
3V/m 80 MHz IEC 60601-
electromagnetic should be used no closer to any
to 2.7 GHz 1-2 Test
fields. IEC part of the device, including
level
ϲϭϬϬϬ-4-3 cables. Minimum distance 30
cm.
2kV for power
supply lines.
Electrical fast IEC 60601- Mains power quality should be
1kV for
transient/burst. 1-2 Test that of a typical commercial or
input/output
/ϲϭϬϬϬ-4-4 level hospital environment.
lines > 3 m

0.5/1kV
differential
IEC 60601- Mains power quality should be
Surge IEC mode 0.5/1kV
1-2 Test that of a typical commercial or
ϲϭϬϬϬ-4-5 common
level hospital environment.
mode

Portable and mobile RF

Conducted
communication equipment
disturbances, 3 V 150 kHz to IEC 60601-
should be used no closer to any
inducted by RF 80 MHz 1-2 Test
part of the device, including
fields. IEC level
cables. Minimum distance 30
ϲϭϬϬϬ-4-6
cm.

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/ϲϬϲϬϭ-1-2 Conformity
Immunity test Electromagnetic environment
test level level
Mains power quality should be
Voltage dips. that of a typical commercial or
0% Un for 0.5
Short hospital environment. If the
cycle. 0% Un
interruptions user of the device requires
for 1 cycle. IEC 60601-
and voltage continued operation during
70% Un for 25 1-2 Test
variations on power mains interruptions, it is
cycles. 0% Un level
power supply recommended that the device
for 5 s
input lines. IEC is powered from an
ϲϭϬϬϬ-4-11 uninterrupted power supply or
battery.
Power
Power frequency of the
frequency IEC 60601-
30 A/m magnetic fields should be that
;ϱϬͬϲϬ,njͿ 1-2 Test
of a typical commercial or
magnetic fields. level
hospital environment.
/ϲϭϬϬϬ-4-8

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3 DEVICE DESCRIPTION
3.1 PROVISION DESCRIPTION

Fig 5 - Provision description

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Pos Denomination Description

A Chin rest optional Adjustable height Adjustable distance
between chin and forehead
B Protection carter Protection against accidental hand
crushing
C Power supplier
D Device AS-OCT Composed by a camera unit equipped
model Ms-39 with one or several micro video
cameras for capturing the images. USB
cable for connection between device
and computer.
E Software optional Software for image capture and
management
F Protective cover optional Place on the device when it is not in
use to protect it from dust
G Set of hex keys optional
with screws
H Package of paper
for chin cup
I Electric table optional Adjustable electric support surface
with one or two columns. Drawer and
auxiliary sockets with fairlead.
J Calibration
ƚŽŽů
K Isolation optional 230V/230V for the use of the non
transformer electro-medical appliances in the
patient area

For the list of accessories and available models contact the

Manufacturer or the local supplier.

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3.1.1 DEVICE AS-OCT

Fig 6 - Device AS-OCT

Pos Description
To Device AS-OCT
B Joystick
C Device blocking knob
D Cogged wheels
E USB connection cable between device andcomputer
F WŽǁĞƌƐƵƉƉůLJconnector
G Device power ƐƵƉƉůLJcable
H Shooting channel
I Calibration ƚŽŽů

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3.1.2 POWER SUPPLIER

Fig 7 - Power supplier

Pos Description
A Data plate
B Power supplier
C Supply control light
D ON/OFF switch
E WŽǁĞƌƐƵƉƉůLJŽƵƚ connector
F Power supply mains connector
G Power supply cable
H Wower ƐƵƉƉůLJcable

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3.1.3 ,/EZ^d;KWd/KE>Ϳ

Fig 8 - Chin rest

Pos Description
A Chin rest support
B Handle
C Knob
D Chin cup
E Forehead rest
F Chin rest structure

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3.1.4 ELECTRIC TABLE (OPTIKE>Ϳ

Different table models are available accordingly to the client's choice.
The electric table is composed by a support surface on which are
installed the cogged guides for the device housing. One or two
telescopic columns, motorized, allow to adjust the height of the
support plane.

Fig 9 - One column table Fig 10 - Two columns table

Read the information for use of the electric table.

3.2 TECHNICAL DATA

Technical data Value
Data transfer USB3
External power supplier 24 VCC. In:
Mains power 100-240Vac - 50/60Hz - 2A - Out:
24Vdc - 100W
Net cable with C14 socket
Dimensions ;,ĞŝŐŚƚdž>ĞŶŐƚŚdžĞƉƚŚͿ 505 x 315 x 251 mm
Weight 10.4 kg
Chin rest stroke 70 mm ±1
Minimum height of the chin cup from
23 cm
the working plan
ĂƐĞŵŽǀĞŵĞŶƚ;dž͕LJ͕njͿ 105 x 110 x 30 mm
Working distance 74 mm

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LŝŐŚƚsources
Technical data Value
Placido Led @635 nm
OCT SLed @845 nm
Pupillography Led @950 nm

Topography
Technical data Value
Placido's disk 22
31232 (anterior surface) 25600
Measured points
(posterior surface)
Topographic covering 10 mm
Dioptric range from 1D to 100D
Class A according to UNI EN ISO 19980-
Accuracy
2012

Section
Technical data Value
Image field 16 mm x 8 mm
Axial resolution 3.6 µm (in tissue)
Transverse resolution 35 µm (in air)
Keratoscopy (640x480) + 25 radial
scans over transverse field of 16
/ŵĂŐĞ;ƐͿƌĞƐŽůƵƚŝŽŶ mm(1024 A-scan) - Section: over 16
mm (1600 A-scan) over 8 mm (800 A-
scan)

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4 DEVICE USE
4.1 HOW TO INSTALL THE DEVICE
CAUTION
Danger of device fall. The electric table must be installed on a
horizontal and stable surface.

1 Place the electric table in the room. The electric table must be
lifted by two people.
2 If present, block the table wheels. Lower the lever of the
brake.
3 Place the power supplier under the support plane. Screw the
screws in the four holes.

Fig 11 - Table placement Fig 12 - Power supplier placement

4 Place the device on the support surface on the cogged guides.

5 Block the two protection carters to the cogged wheels on the
support plane.

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Fig 13 - How to place the device Fig 14 - Protection carters placement

6 Chin rest install. Under the support plane, there are two
screws to block the chin rest support to the support plane.
7 Carry out the electrical connection between the several
components.

Fig 15 - Chin rest placement

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4.2 HOW TO CONNECT THE DEVICE

Fig 16 - Device connection

Pos Denomination
A USB connection cable between device and PC
B Power cable for the connection of the electric table with the power
supply
C Power cable for the connection of the electric table with the power
supplier
D Power cable for the connection between the power supplier and the
device

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4.3 HOW TO PLACE THE ELECTRIC CABLES

CAUTION
Danger of device fall. 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 leave the power supply cables in contact
with sharp corners or objects. Untie the knots and unwind the
power supply cables.

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

manufacturer.

Fig 17 - Power sockets position Fig 18 - Wireway

The power socket is on the column of the electric table, below, and it
has to be used for the connection with the mains power. The power
sockets on the column of the electric table, on top, are dedicated to
the tools and power suppliers. Block the cables under the support
surface with the cable rivets. If you have it, place the cables in the
wireway under the support plane.

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4.4 HOW TO TURN ON THE DEVICE

1 Turn on the PC.
2 Push the activation switch of the power supplier on ON.
3 Launch the application software Phoenix.
4 Wait that the main screen of the software is shown.
5 Click on NEW PATIENT and enter his personal data. If the
patient is already present in the database, you can
automatically research the surname in the surname command
line.
6 A new examination will be created automatically.
7 Select the tool to use.
8 The image capture window will open. Now it will be possible to
capture the image.

Creation of a new exam

- Click on the button NEW EXAMINATION.
- Select the tool to use.
- The image capture window will open. Now it will be possible to
capture the image.

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4.5 ADJUST THE CHIN REST

1 Tell the patient to take a seat.
2 Ask the patient to put the chin on the chin cup and the
forehead against the forehead rest.
3 Verify the correct eyes position respectively to the shooting
channel.

Fig 19 - Patient position on the chin rest

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4 Lift or lower the chin cup as needed.

Fig 20 - Knob rotation Fig 21 - Chin cup placement

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4.6 HOW TO CAPTURE THE IMAGE

1 Turn the joystick and align the device with the patient's eye.
2 Move towards the eye with the tool. Keep centered the
reflection of the corneal vertex in both the images.
3 Perform some micro movements with the joystick to obtain
the best image alignment.

Fig 22 - How to place the device Fig 23 - Distance from the patient

4 Push down the joystick to confirm and capture the image. The
image will be saved in the gallery.
5 Double click on the captured image to process and visualize
on the computer screen.

Fig 24 - Image capture

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Refer to the software instructions for the image managing in the

database.

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4.7 HOW TO CHANGE THE PAPER FOR CHIN CUP

At the end of each exam remove the paper for chin cup in order to
always have a new and hygienic one for the next patient.

This device is provided with a package of paper for chin cup. When you
use the last paper change the package.
1 Extract the two plastic rivets
2 Place the new package of paper for chin cup
3 Insert the plastic rivets in the holes of the package and in the
holes of the chin cup.

Fig 25 - How to change the papers for chin cup

To order the spare package see the code in the "Spare parts list page
43"

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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 Immobilize the device. Turn the locking knob.

2 Exit the images management systems program. Turn off the
computer
3 Push the activation switch of the power supplier on OFF.
4 Place the protective cover on the device to prevent dust to fall
on the device.

Fig 26 - Device blocking

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5 ORDINARY MAINTENANCE
5.1 SAFETY WARNINGS
DANGER
Electric shock danger. Unplug the power cable from the mains
socket before disinfecting the device and before any maintenance
operation.

CAUTION
The device does not contain any piece that requires the user's
intervention. Do not dismantle any part of the device.

it is forbidden to carry out any maintenance operation on the device

that is not recalled in the information for use.

In case of operational faults or malfunctions or for every operation

not mentioned in the information for use, there is the obligation to
address an authorized technical assistance center of the device
Manufacturer.

5.2 DEVICE CLEANING

Clean the external parts of the device using a damp non-abrasive cloth
to avoid damaging the material.
CAUTION
Danger of material damages. Do not use solvents or diluent to clean
the device.

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5.3 SPARE PARTS AND ACCESSORIES LIST

Code Description
ϯϬϬϭϬϬϳϭϯ& Power supply cable
Isolation transformer 230V/230V. Power supply
ϭϬϭϬϭϯϬϬ
cable 800 VA (maximum charge)
ϰϬϭϰϬϮϬ Package of paper for chin cup (50 pieces)
ϰϬϭϯϬϵϬ Protective cover
ϭϬϬϳϬϱϮϰ Table top 45x90 mm
Electric support plane with one column (230 V, 50
ϭϬϯϯϬϭϴϬϬ
Hz)
Mobile multivoltage table (100-240V 50-60Hz) with
ϭϬϯϭϬϲ,ϬϬ double column for support plane for OCT instrument
and PC screen
ϯϯϬϳϭϬϵϱ Power supply cable for electric support (95 cm)
PSP2402 input 100-240 V AC 50/60 Hz max 0,9 A
ϭϬϯϭϬϯϵϬϬ
output 24 VDC 2 A
ϯϬϬϰϬϵϭϯϱ Power supply cable 1,5 m
ϯϬϬϰϬϵϭϯϲ Power supply cable 5 m
ϭϬϯϭϬϲϮϬϬ Calibration set for corneal maps
ϭϬϬϭϬϰϳϬϬ Chin rest for the table top
ϯϬϮϬϭϱϬ USB 3.0 Cable 5 m

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5.4 TROUBLESHOOTING
Inconvenient Cause Solution Note
If the device is
powered trough
Connect the the auxiliary
Power cable not power cable of power supply of
The device does connected with the device to the the table, check
not switch on the power power supplier the connection of
supplier Press the switch the table to the
on of the device. power line. Check
the functioning of
the table fuses.
Connect the
power cable to
Power cable not the power Make sure the
The PC does not connected with supplier. Push the power outlet of
start the power button of the the room works
supplier power supplier on properly.
ON. Replace the
PC.
Make sure the
PC Operating Hard Disc failure. Replace the Hard
New PC features
system does not Operating system Disc. Reinstall the
are equivalent or
start failure operating system.
higher.

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Inconvenient Cause Solution Note

Replace the Hard
Hard Disc failure. Disc. Check the
The anti virus settings of the
software impedes anti virus
The installation of
the starting of the software.
The software the Phoenix
Phoenix software. Reinstall the
Phoenix does not software needs
The Phoenix Phoenix software
start the administrator
software does not with
privileges.
work properly. administrator
Operating system privileges.
failure Reinstall the
operating system.
Unplug and plug
The connection in again the
cable between connection cable
device and PC between device
does not work and PC. Replace Try to uninstall
properly. The anti the connection the anti virus
The Phoenix
virus software cable between software. Unplug
software does
interferes with device and PC. and plug in again
not work
the drivers of the Uninstall the anti the connection
properly.
Phoenix software. virus software. cable between
The Phoenix Reinstall the device and PC.
software is Phoenix software
installed as local with
user administrator
privileges.

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Inconvenient Cause Solution Note

Check that the
Connection cable
mouse
with the PC
connection cable
disconnected. From the control
properly fit in USB
Mouse switch in panel of the PC,
The mouse of the port. Switch the
position OFF. The check that there
PC does not work mouse button in
mouse batteries are no devices
position ON.
are down (only conflicts.
Replace mouse
for wireless
batteries (only for
mouse)
wireless mouse).
Check that the
Connection cable
keyboard
with the PC
connection cable
disconnected.
properly fit in USB From the control
Keyboard switch
The keyboard of port. Switch the panel of the PC,
in position OFF.
the PC does not keyboard button check that there
The keyboard
work in position ON. are no devices
batteries are
Replace keyboard conflicts.
down (only for
batteries (only for
wireless
wireless
keyboard)
keyboard).

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Inconvenient Cause Solution Note

Verify that in the
configuration
window of the
database is
The database is specified the
not connected correct path to
with the Phoenix the
The images can't Regularly verify
software. Power “phoenix.mdb”
be saved in the the connections
connection file. Restore the
database with the data net.
absent. The USB connection to the
cable does not database file.
work Check the
functioning of the
net connection.
Replace the USB
cable.
Ask the patient to
The patient keep the eyes
Failed image moved or closed open, look the
capture the eyes during fixation light and
the capture not to move the
eyes.
The tear film is
Poor image not well Ask the patient to
quality from distributed on the close and open
Placido's disk cornea surface the eyes.
(dry eye)
Presence of dust Make sure the
Failed image Clean the surface
of grease on the patient does not
focus from of optical parts
optical parts of touch the optical
Placido's disk with a soft cloth.
the device. parts.

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Inconvenient Cause Solution Note

Some colors and
material of the
table top may not
Missing
Missing Install the black reflect the
installation of
acknowledgment sticker below the infrared light.
black sticker
of eye position base of the Move a white
below the base of
left / right device. Replace paper below the
the device. Fault
position by the the positioning base of the device
of positioning
device detector. to check the
detector
functioning of the
positioning
detector.
The joystick
Remove the
plastic protection
Device joystick plastic Before starting
has not been
movement protection from the exam check
removed from
difficulties the base. that the device
the base during
(ahead, back, Unscrew the blocking knob is
the installation.
ůĞĨƚ͕ƌŝŐŚƚͿ device blocking unscrewed.
Device blocking
knob.
knob is fastened

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COSTRUZIONE STRUMENTI OFTALMICI

phone: +39 055 722191 | fax: +39 055 721557

[email protected] | www.csoitalia.it

MS-39 | IFUMS-39 00 del 0/201