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Summary of Contents for CSO MS39 AS-OCT
- Page 1 COSTRUZIONE STRUMENTI OFTALMICI MS-39 INSTRUCTIONS FOR USE AS-OCT COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it IFU302EN00 - 03/2019 0051 1/174...
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Page 3: Table Of Contents
PAPERS .............. 44 OW TO CHANGE THE CHIN CUP ................45 OW TO TURN OFF THE DEVICE ORDINARY MAINTENANCE ..............46 This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 1/52... - Page 4 MS-39 AS-OCT| IFU302EN00 - 03/2019 ................... 46 AFETY WARNINGS ..................... 46 EVICE CLEANING ..............47 PARE PARTS AND ACCESSORIES LIST ..................48 ROUBLESHOOTING This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 2/52...
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Page 5: Introduction
Note. Useful information for the user General prohibition sign Manufacturer CE Marking (Directive 93/42/EEC) Identification number of the notified body (IMQ) This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 3/52... -
Page 6: Device Symbols
Authorized Service Centre. Verify the presence of damage signs on the device caused by the transport/storage, before using the device. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 4/52... -
Page 7: Normative References
1.3.3 QUALITY MANAGEMENT SYSTEMS STANDARDS UNI CEI EN ISO 13485:2016 “Medical devices. Quality management systems - Requirements for regulatory purposes”. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 5/52... -
Page 8: Warranty
Manufacturer damages caused by service lack or inefficiency, originating by causes or circumstances out of the Manufacturers control This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 6/52... -
Page 9: Manufacturer Identification
CSO S.r.l. Costruzione Strumenti Oftalmici Via degli Stagnacci, 12/E 50018 - Scandicci (FI) - ITALY phone: +39-055-722191 - fax +39-055-721557 cso@csoitalia.it www.csoitalia.it This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 7/52... -
Page 10: Safety
CAUTION Electric shock risk. Do not touch the power supply cables with wet hands. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 8/52... - Page 11 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. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 9/52...
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Page 12: Device Identification
Salute website at this page: Ministero della Salute - Ricerca dispositivi 2.2.2 DEVICE DATA PLATE Fig 1 - Plates position Description Device data plate This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 10/52... -
Page 13: Power Supply Data Plate
MS-39 AS-OCT| IFU302EN00 - 03/2019 Fig 2 - Device data plate 2.2.3 POWER SUPPLY DATA PLATE Fig 3 - Power supply PSP2404 data plate This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 11/52... -
Page 14: Intended Use
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. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 12/52... - Page 15 This allows the planning of the corneal surgery for refractive defects, either photoablative and by means of intraocular lens implants. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 13/52...
- Page 16 Ocular Surface Disease Index (OSDI) analysis of the redness of the eye Analysis of Meibomian glands Tear meniscus analysis NiBUT. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 14/52...
- Page 17 PSF, Spot Diagram, MTF and vision simulation for the analysed wavefront This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 15/52...
- Page 18 Dry Eye Report For system requirements read paragraph "Personal Computer” at page 30. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 16/52...
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Page 19: Medical Devices Classification
MEDICAL DEVICES CLASSIFICATION Technical data Value Classification in compliance with the attached IX to the Directive Class IIa 93/42/EEC and subsequent modifications This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 17/52... -
Page 20: Medical Electrical Devices Classification
15 weeks, only if kept in the original packaging. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 18/52... -
Page 21: Disposal At The End The Useful Life
This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 19/52... - Page 22 Strict sanctions for transgressors are provided for by law. For specific information about the disposal in other countries than Italy, contact the local Dealer. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 20/52...
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Page 23: Manufacturer Declarations
Compliant fluctuations and flicker. connected directly to a low-tension IEC 61000-3-3 power supply net as there is in the housing units. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 21/52... - Page 24 RF 80 MHz 1-2 Test part of the device, including fields. IEC level cables. Minimum distance 30 61000-4-6 This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 22/52...
- Page 25 (50/60Hz) 30 A/m 1-2 Test of a typical commercial or magnetic fields. level hospital environment. IEC 61000-4-8 This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 23/52...
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Page 26: Device Description
Optional: accessory not provided with the basic supply Accessories marked by (*) are essential for the proper functioning of the device. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 24/52... - Page 27 For the list of accessories and available models, contact the Manufacturer or the local Distributor. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 25/52...
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Page 28: Device Ms -39 As-Oct
Device blocking knob Cogged wheels USB connection cable between device and computer Power port Device power cable Shooting channel Calibration rod This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 26/52... -
Page 29: Power Supply Unit
Power supply unit Supply status control light ON/OFF switch Power supply out connector Power supply mains connector Power supply cable Device power cable This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 27/52... -
Page 30: Chin Rest
Fig 8 - Chin rest Description Chin rest support Handle Chin cup adjustment knob Chin cup Forehead rest Chin rest structure This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 28/52... -
Page 31: Ophthalmic Table
Fig 9 - One column table Read the instructions for use of the ophthalmic table. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 29/52... -
Page 32: Personal Computer
The accessories (printer, modem, scanner, etc) must be installed outside the patient area. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 30/52... -
Page 33: Technical Data
105 x 110 x 30 mm Working distance 74 mm Light sources Technical data Value Placido Led @635 nm SLed @845 nm Pupillography Led @950 nm This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 31/52... - Page 34 16 mm Image(s) resolution (1024 A-scan) - Section: over 16 mm (1600 A-scan) over 8 mm (800 A-scan) This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 32/52...
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Page 35: Device Use
Place the power supply under the support plane. Screw the screws in the four holes. Fig 11 - Table placement Fig 12 - Power supply unit placement This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 33/52... - Page 36 Respect the indicated distances while placing the sticker pad (for right/left identification) on the table top. Fig 13 – Distances Fig 14– How to place the sticker pad This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 34/52...
- Page 37 Install the chin rest. Under the support plane, there are two screws to block the chin rest support to the support plane. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 35/52...
- Page 38 MS-39 AS-OCT| IFU302EN00 - 03/2019 Carry out the electrical connection between the several components. Fig 18 - Placing the chin rest This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 36/52...
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Page 39: How To Connect The Device
Power cable for the connection of the electric table with the power supply To power the table basement, read instructions for use of the table or of the ophthalmic unit. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 37/52... -
Page 40: How To Place Electric Cables
One of the power sockets on the upper part of the elevation column is dedicated to the device power supply unit. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 38/52... -
Page 41: How To Turn On The Device
Select the tool to be used. The image capture screen will open. Now it will be possible to capture the image. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 39/52... -
Page 42: How To Adjust The Chin Rest
Verify the correct eyes position respectively to the shooting channel. Fig 20 - Patient position on the chin rest This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 40/52... - Page 43 MS-39 AS-OCT| IFU302EN00 - 03/2019 Lift or lower the chin cup as needed. Fig 21 - Knob rotation Fig 22 - Placing the chin cup This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 41/52...
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Page 44: How To Capture The Image
Double click on the captured image to process and visualize on the computer screen. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 42/52... - Page 45 MS-39 AS-OCT| IFU302EN00 - 03/2019 Fig 25 - Image acquisition Refer to the application software instructions for the image managing in the database. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 43/52...
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Page 46: How To Change The Chin Cup Papers
Fig 26 - How to change the chin cup papers To order a spare part read the code in the “Spare parts list at page 47” This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 44/52... -
Page 47: How To Turn Off The Device
Push the activation switch of the power supply on OFF. Place the protective cover on the device to prevent dust to fall on the device. Fig 27 - Device blocking This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 45/52... -
Page 48: Ordinary Maintenance
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. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 46/52... -
Page 49: Spare Parts And Accessories List
USB 3.0 cable 5 m For spare parts or accessories not included in the list, ask the Manufacturer or the local Dealer. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 47/52... -
Page 50: Troubleshooting
Disk. Reinstall the system does not Spoiled operating are equivalent to operating system. start system. those required by Replace the PC the device. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 48/52... - Page 51 Phoenix. privileges. Reinstall the The application application software Phoenix software Phoenix is installed as with local user administrator privileges. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 49/52...
- Page 52 ON. are no devices batteries are Replace keyboard conflicts. down (only for batteries (only for wireless wireless keyboard) keyboard). This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 50/52...
- Page 53 Placido's disk with a soft cloth. the device. parts. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 51/52...
- Page 54 Loosen (ahead, back, blocking knob is the installation. the device left, right) loosened. Device blocking blocking knob. knob is fastened This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 52/52...
- Page 56 4/174 COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it MS-39 AS-OCT | IFU302EN00 - 03/2019...
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