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INSTRUCTIONS FOR USE

| IFU327EN00 - 01/2021

This document is the property of
CSO Costruzione Strumenti Oftalmici srl.
Any reproduction, even partial, it is prohibited.

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SAFETY

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 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 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 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.

Summary of Contents for sirius+

Page 1: ...S FOR USE sirius COSTRUZIONE STRUMENTI OFTALMICI 1 174 EN COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it 0051 Corneal Topograph Tomograph IFU327EN00 01 2021 ...

Page 2: ......

Page 3: ...TENDED 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 3 DEVICE 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 Pe...

Page 4: ...ICE 47 5 ORDINARY 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...

Page 5: ...lity 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 pro...

Page 6: ...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 f...

Page 7: ...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...

Page 8: ... 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...

Page 9: ... 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 S...

Page 10: ...k 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 falling down Do not leave free cables which can re...

Page 11: ...st 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 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 subjec...

Page 12: ...t is prohibited 10 56 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 ...

Page 13: ...mation 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...

Page 14: ...rform 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 desc...

Page 15: ...e 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 ...

Page 16: ... 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 ...

Page 17: ...lity 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...

Page 18: ...aph 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...

Page 19: ...n 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...

Page 20: ...revents 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 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 se...

Page 21: ... 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 Manufactu...

Page 22: ...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 voltage 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 de...

Page 23: ...ial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality shall be that of a typical commercial or hospital environment Voltage dips Short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Un for 0 5 cycles 40 Un for 5 cycles 70 Un for 25 cycles 5 Un for 5 s 5 Un for 0 5 cycles...

Page 24: ...r d 1 167 sqrt P d 1 167 sqrt P 80 MHz to 800 MHz d 2 333 sqrt P 800 MHz to 2 5 GHz P is the maximum output power rating of the transmitter in watts W according to the transmitter Manufacturer d is the recommended distance in metres m at which the portable radio frequency RF appliances can be used Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be ...

Page 25: ...Strumenti Oftalmici srl Any reproduction even partial it is prohibited 23 56 3 DEVICE DESCRIPTION 3 1 SUPPLY DESCRIPTION Fig 5 Supply description Optional accessory not provided with the basic supply For the list of accessories and available models contact the Manufacturer or the local Distributor ...

Page 26: ...posed by a camera unit equipped with one or several micro video cameras for capturing the images USB cable compatible with the device for the connection between power supply unit and computer G Application software Application software for image capture and device management H Protective cover Place on the device when it is not in use to protect it from dust I Hex wrench with screws J Package of c...

Page 27: ...ftalmici srl Any reproduction even partial it is prohibited 25 56 3 1 1 DEVICE SIRIUS Fig 6 Device sirius Pos Description A Device sirius B Joystick C Device blocking knob D Cogged wheels E Connection cable between device and power supply unit F Connection cable between device and computer G Shooting channel ...

Page 28: ...mici srl Any reproduction even partial it is prohibited 26 56 3 1 2 POWER SUPPLY UNIT Fig 7 Power supply unit Pos Description A Data plate B Power supply unit C Power supply status control light D ON OFF switch E Power supply out connector F Power supply mains connector G Power supply cable H Device power cable ...

Page 29: ... Any reproduction even partial it is prohibited 27 56 3 1 3 CHIN REST Fig 8 Chin rest Pos Description A Chin rest support B Handle C Chin cup adjustment knob D Adjustable chin cup E Forehead rest F Chin rest structure The chin rest support can be different depending on the table top where the chin rest will be installed ...

Page 30: ...LMIC TABLE 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 The table has one or two telescopic columns motorized that allow to adjust the height of the support table top Fig 9 One column table Read the instructions for use of the ophthalmic table ...

Page 31: ...4 bit Read the instructions for use of the application software Fig 10 Personal Computer 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 insulating transformer compliant with the directive IEC 60601 1 2005 A1 2012 Medical electrical equipment Part 1 General ...

Page 32: ...electrical equipment Part 1 General requirements for basic safety and essential performance 3 2 TECHNICAL DATA Technical data Value Data transfer USB 3 0 Mains power External power supply unit 24 VCC In 100 240Vac 50 60Hz 0 9 05A Out 24Vdc 40W Net cable with C14 socket Dimensions Height x Length x Depth 515 x 315 x 255 mm Weight 7 kg Chin rest stroke 70 mm 1 Minimum height of the chin cup from the...

Page 33: ...sured points From 41932 to 150832 anterior surface From 41932 to 145200 posterior surface Topographic covering 12 mm Dioptric range from 1D to 100D Accuracy Class A according to UNI EN ISO 19980 2012 Accessories Technical data Value Light diffuser filter for auxiliary illumination Magnetic light diffuser filter Yellow barrier filter Magnetic 530 nm filter Additional lens Magnetic 6D lens Calibrati...

Page 34: ...LL THE DEVICE CAUTION Danger of device falling down The table must be installed on a horizontal and stable surface 1 Place the ophthalmic table in the room The table must be lifted by two people 2 If present block the table wheels Lower the lever of the brake 3 Place the power supply unit under the table top Fasten the screws to the four holes Fig 11 Table placement Fig 12 Power supply unit placem...

Page 35: ...t is prohibited 33 56 4 Verify the sticker position respectively to the central axis A 5 Remove the protection film Place the sticker pad between the two cogged wheels and the scrolling plate Respect the indicated distances while placing the sticker pad for right left identification on the table top Fig 13 Distances Fig 14 Placement of the sticker pad ...

Page 36: ...ial it is prohibited 34 56 6 Remove the joystick protection A placed under the device base Fig 15 Protection removal 7 Place the device on the table top and align the cogged wheels on the cogged guides 8 Fasten the two wheel cover carters to the cogged wheels on the table top Fig 16 Placement of the device Fig 17 Placement of wheel cover carters ...

Page 37: ...partial it is prohibited 35 56 9 Install the chin rest Under the table top there are two screws to block the chin rest support to the table top The chin rest shall be installed so that the eye level indicator 1 is placed at a height of 380 mm from the table top Fig 18 Placement of the chin rest Fig 19 Correct height of the eye level indicator ...

Page 38: ...ght adjust the chin rest 11 Loosen the 4 locking grub screws placed on the chin rest support 12 Slide the chin rest rods until reaching the required height of 380 mm Tighten the previously loosened locking grub screws The chin rest rods shall be adjusted upwards no more than 18 mm Fig 20 Loosening the chin rest grub screws Fig 21 Maximum height for rods adjustment 13 Carry out the electrical conne...

Page 39: ... 37 56 4 2 HOW TO CONNECT THE DEVICE Fig 22 Device connection Pos Denomination A 3 0 USB connection cable between device and PC B Power cable for the connection of the electric table to the power supply C Cable for the connection between the power supply unit and the device To power the table basement read instructions for use of the table or of the ophthalmic unit ...

Page 40: ...ock risk Do not leave the power supply cables in contact with sharp corners or objects Collect and attach always the power supply cables It is forbidden to use any extension cable not authorized by the manufacturer For the proper placement of electrical cables and connection to the elevation column read instructions for use of ophthalmic tables or of ophthalmic units The instruction manual can als...

Page 41: ... calibration on page 39 4 4 1 HOW TO PERFORM DEVICE CALIBRATION Calibration shall be performed when starting the device for the first time or after a long period of inactivity of the latter The procedure shall be carried out in a dark room so as to simulate the environmental conditions of a standard capture procedure Follow the instructions about calibrating the device sirius which are given in th...

Page 42: ... the calibration procedure Carefully follow the given instructions 8 Align the red cross with the centre of Placido s rings reflected on the sphere 8 mm radius 9 Place the device at the correct distance from the sphere The correct distance is such that the white arc corresponding to the reflection of the blue slit on the sphere surface touches the red horizontal line displayed on the upper part of...

Page 43: ...he value of the reference sphere corresponds to that on the anterior tangential curvature map 19 If the elaborated measures are not considered reliable repeat the whole calibration procedure In case the device is not properly calibrated Repeat the calibration procedure 4 4 2 HOW TO CREATE A NEW PATIENT 1 Click on NEW PATIENT and enter his personal data If the patient is already present in the data...

Page 44: ...oduction even partial it is prohibited 42 56 4 5 HOW TO ADJUST THE CHIN CUP 1 Inform the patient to take a seat 2 Move the chin cup left or right The chosen position will identify the position of the eye to be tested Fig 25 Adjusting the chin cup Fig 26 Chin cup orientation for left eye Fig 27 Chin cup orientation for right eye ...

Page 45: ...uzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 43 56 3 Ask the patient to put the chin on the chin cup and the forehead against the forehead rest 4 Check the eye is correctly placed respectively to the shooting channel Fig 28 Patient position on the chin rest ...

Page 46: ...pture the image on page 45 Fig 29 Knob rotation Fig 30 Chin cup placement 7 At the end of the acquisition procedure ask the patient to lift their face up 8 Move the chin cup in the opposite direction to that chosen before 9 Ask the patient to put the chin on the chin cup and the forehead against the forehead rest 10 Check the eye to be tested is correctly placed respectively to the shooting channe...

Page 47: ...tool Keep centred the reflection of the corneal vertex in both the images 3 Perform some micro movements with the joystick for the best image alignment Fig 31 Placement of the device Fig 32 Distance from the patient 4 Press the joystick button to 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 33 Imag...

Page 48: ...n order to always have a new and hygienic one for the next patient This device is provided with a package of chin cup papers When you use the last paper change the package 1 Extract the two plastic rivets 2 Place the new package of chin cup papers 3 Insert the plastic rivets in the holes of the package and in the holes of the chin cup Fig 34 Changing chin cup papers To order a spare part read the ...

Page 49: ... 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 Press the activation switch of the power supply unit on OFF 4 Place the protective cover on the device to prevent dust to fall on the device Fig 35 Bloc...

Page 50: ...forbidden to carry out any maintenance operation on the device that is not recalled in instructions for use In case of operational faults or malfunctions or for every operation not mentioned in the instructions for use there is the obligation to address an authorized technical assistance centre of the device Manufacturer 5 2 CLEANING AND DISINFECTION CAUTION Carefully follow the instructions about...

Page 51: ...lication The current section described the procedures to be carried out during use and maintenance in order ensure proper cleaning and disinfection of the device and its accessories 5 2 1 RECOMMENDED PRODUCTS FOR CLEANING AND DISINFECTION CAUTION Danger of material damages Do not use solvents acidic or basic solutions pH 4 5 or 8 0 abrasive or caustic substances chlorine based and chlorine derived...

Page 52: ...ohol 70 v v alcohol or isopropyl alcohol For information about using the chosen product please comply with the instructions provided by the manufacturer 5 2 2 CLASSIFICATION OF THE DEVICE FOR HYGIENE AND SAFETY CAUTION The device is supplied non sterile and it shall not be sterilized prior to use This device is classified as non critical since it is only used on healthy skin and therefore has a lo...

Page 53: ... device and the accessories CAUTION Danger of material damages Clean using a non abrasive cloth to avoid damaging the surface The device shall be regularly cleaned The device is provided with a cover whose function is to protect it from dust especially during periods of non use Clean the outer parts of the device using a damp non abrasive cloth and a rinse free cleansing solution For more informat...

Page 54: ... surface disinfection they may contain aldehyde Alternatively use a non abrasive cloth soaked in a solution of water ethyl alcohol 70 maximum or isopropyl alcohol For more information about suitable cleansing products read the Recommended products for cleaning and disinfection paragraph on page 49 5 2 5 CLEANING THE OPTICAL COMPONENTS CAUTION Danger of material damages The device is equipped with ...

Page 55: ...20 Package of chin cup papers 50 pieces 4013095 Protective cover 10070144 Electric table top with one column 230 V 50 Hz 33071095 Power supply cable for electric support 95 cm 103103900 PSP2402 input 100 240 V AC 50 60 Hz max 0 9 A output 24 VDC 2 A 100130201 Calibration tool 100130700 Chin rest with adjustable chin cup 963107100 Kit with additional lenses yellow filter for Fluorescein exam negati...

Page 56: ...le to the power supply unit Press the button of the power supply unit on ON Replace the PC Make sure the power outlet of the room works properly PC Operating system does not start Hard Disk failure Spoiled operating system Replace the Hard Disk Reinstall the operating system Replace the PC Make sure the New PC features are equivalent to those required by the device The application software Phoenix...

Page 57: ...nstallation of the application software Phoenix needs the administrator privileges The mouse of the PC does not work Connection cable with the PC disconnected Mouse switch in position OFF The mouse batteries are down only for wireless mouse Check that the mouse connection cable properly fit in USB port Switch the mouse button in position ON Replace mouse batteries only for wireless mouse From the ...

Page 58: ...apture The patient moved or closed the eyes during the capture Ask the patient to keep the eyes open look the fixation light and not to move the eyes Poor image quality from Placido s disk The tear film is not well distributed on the cornea surface dry eye Ask the patient to close and open the eyes Failed image focus from Placido s disk Presence of dust of grease on the optical parts of the device...

Page 59: ......

Page 60: ...COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it 4 174 sirius IFU327EN00 01 2021 ...

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