bon EM-2 Instructions For Use And Maintenance Manual

Specular microscope

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Specular Microscope EM-2

Instructions for Use and Maintenance

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Page 1 Specular Microscope EM-2 Instructions for Use and Maintenance...
Page 2 Internet: www.bon.de IBAN: DE 2305 0101 0001 0148 85 (Sort code 200 100 20) Acc.No. 409 22-204 bon Optic Vertriebsgesellschaft mbH – Managing Director: H. Jochen Kaber – HR Lübeck, HRB 3475 – VAT No. 161662634 Page 1 of 45...
Page 3: Table Of Contents
CONTENTS 1. INTRODUCTION ................................4 2. GENERAL SAFETY PRECAUTIONS ........................4 3. BRIEF DESCRIPTION OF THE INSTRUMENT – USES..................5 3.1. ACCESSORIES.................................6 4. OPERATING CONDITIONS ............................6 5. END-OF-LIFE DISPOSAL ENVIRONMENTAL CONSIDERATION ..............7 6. LEGEND ..................................8 7. INSTALLATION................................9 7.1. UNPACKAGE THE INSTRUMENT AND REASSEMBLING THE OPTICAL HEAD (23) ........9 7.2.
Page 4 9. OPERATING FEATURES............................37 10 ROUTINE MAINTENANCE .............................38 10.1 REPLACING THE LINE FUSES ..........................38 10.2 REPLACING THE MONITOR FUSE ........................38 10.3 REPLACING THE HALOGEN (28) AND/OR FLASH (27) LAMP ..............38 10.4 PROTECTING THE INSTRUMENT FROM DUST.....................39 11. TECHNICAL DESCRIPTION..........................40 11.1 CLASSIFICATION ACCORDING TO EN 60601 STANDARD .................40 11.2 FUNCTION BLOCK DIAGRAM..........................41 11.3 DATA PLATE SYMBOLS ............................42 12.
Page 5: Introduction
Thank you for having purchased EM-2 by bon Optic All bon Optic products are manufactured to rigorous safety standards. particular, the SP 01 specular microscope is a high-performance instrument. In order to use it efficiently and in complete safety we recommend reading this manual carefully before beginning installation and heeding all the safety warnings provided herein and on the instrument labels.
Page 6: Brief Description Of The Instrument - Uses
• Automatic focusing of the endothelial layer of the cornea. • Automatic search for cell borders and broad-based statistical analysis of the data. The bon Optic specular microscope is an indispensable aid in diagnosing corneal health. Page 5 of 45...
Page 7: Accessories
• local anesthetics. The instrument is composed of: the SPECULAR MICROSCOPE as such, designed and built by bon Optic, and the user accessories listed below: 1. 15.1” LCD monitor (50 W max. power requirement); 2. Keyboard;...
Page 8: End-Of-Life Disposal Environmental Consideration
The symbol in the margin indicates that the end-of-life instrument must not be disposed of as normal waste. The various materials of which the instrument is made, as well as the packing materials, must be separated for disposal by type and in accordance with local laws and waste recycling regulations.
Page 9: Legend
Chin rest height adjustment knob. LCD monitor. Paper-holder pins on chin rest. Instrument computer ON pushbutton. Chin rest. Optical unit. Mouse. Keyboard. Instrument head assembly screws. Forehead rest. Power socket with fuse holder compartment and voltage changer. Main switch. Data plate. USB socket (printer connector).
Page 10: Installation
The instrument as supplied is packed for best withstanding standard shipping and warehousing conditions. Should you notice defects attributable to shipping when unpacking the instrument, contact your installation service. 7.1. UNPACKAGE THE INSTRUMENT AND REASSEMBLING THE OPTICAL HEAD (23) For reasons of mechanical safety, the instrument is shipped with the optical head disassembled and separately packed.
Page 11 occluded corneas. It may be impossible to acquire images of the epithelium of the corneas of these subjects. Always check that the patient’s chin is correctly positioned on the chin rest and his forehead is firmly placed against the forehead rest. There are endothelia which could be acquired with a certain difficulties, and can give ambiguous result.
Page 12: Instructions For Use
8.1. LAUNCHING THE SOFTWARE All the software required for using the BON OPTIC specular microscope is pre-installed on the instrument’s built-in computer. This PC does not support installation of other types of software. In order not to jeopardize the instrument performance level and/or correct operation, do not install software for other uses on this PC.
Page 13: Toolbar Buttons Summary
8.3. TOOLBAR BUTTONS SUMMARY BUTTON KEYBOARD ICON FUNCTION SHORTCUT Opens the general settings and database settings Settings panel. New Patient Allows the user to create a new patient. Allows the user to create a new examination. New Exam Capture Space bar Accesses the CAPTURE screen.
Page 14: Groups
8.4.2 GROUPS Select the GROUPS menu to manage the pathology groups to be assigned to each examination, distinguishing between right eye and left eye (OD/OS) (Fig. 5). Click the button to create a new group. Click the button to edit a pre-existing group.
Page 15: Dicom
one time in the patients list. In the Figure 6 example: 100 examinations. 8.4.4 DICOM If the Suppress DICOM warnings box is selected, the menus and alarm messages referred to DICOM management will not be displayed. Deselecting this box allows the user to manage the PACS and PMS configurations needed for DICOM data transfer.
Page 16: Capture
8.6 CAPTURE 8.6.1 CAPTURE WINDOW COMMANDS KEYBOARD BUTTON ICON FUNCTION SHORTCUT Allows the user to select the correction to be applied for different corneal thicknesses. Sensitivity Allows the user to select the video camera sensitivity threshold (High, Normal, Low) for working with opaque, normal, and highly reflective corneas, respectively.
Page 17 Now position the patient’s head on the right side of the chin rest to capture the left eye or, vice-versa, on the left side to capture the right eye. Check that the patient’s chin is solidly positioned on the chin rest and the forehead on the forehead rest.
Page 18: Anonymous Capture
To view the preview of another image, simply select it. Double-click the gallery image to proceed with processing. Fig. 11 – Gallery image 8.7 ANONYMOUS CAPTURE This new capture mode permits capturing and processing an image without attributing it to any patient.
Page 19: Capturing Corneas With Different Thicknesses
8.8 CAPTURING CORNEAS WITH DIFFERENT THICKNESSES A new cursor has been added to regulate the quality of capture of corneas with differing thicknesses. This cursor contains various values from -5 to +5 with a default 0 position at the center. In general, if the patient is correctly positioned and the cornea is normal, the cursor may be left in the 0 position.
Page 20 If the left edge of the image corresponds to a positive value, repeat capture after setting the cursor to the corresponding scale value. In the example (Figure 15), repeat the capture with the thickness value set to “+2.” Fig. 15 – Positive correction If the left edge of the image corresponds to a negative value, repeat capture after setting the cursor to the corresponding scale value.
Page 21: Remote Control
8.9 REMOTE CONTROL The new SP-02 is equipped with an infrared remote control for greater operator convenience when using the instrument. The remote can be used to: switch off the instrument. align and focus the corneal reflection before beginning capture. select the area of the cornea to capture.
Page 22: Using The Remote Control For Image Capture
8.11 USING THE REMOTE CONTROL FOR IMAGE CAPTURE Follow the procedure outlined below when using the remote control for image capture. Position the patient’s head on the chin rest, which automatically detects the right eye (OD) or the left eye (OS). Click the “capture”...
Page 23: Examples
To begin the examination, press the OK key on the remote or press the SPACE BAR. The instrument will automatically capture image endothelium and, at the end of this operation, display it in the gallery. 8.11.1 EXAMPLES In order for the pachymetric datum supplied by the instrument to be reliable, the image must be perfectly focused and the left edge of the captured image must correspond to the “0”...
Page 24 If the left edge of the image corresponds to a positive value, repeat capture after setting the cursor to the corresponding scale value (Fig. 21). In the example, repeat the capture after setting the thickness value to “+2” using the remote control key.
Page 25: Automatic Cell Count
8.12 AUTOMATIC CELL COUNT Double-click the gallery image to access the environment for processing the captured image. The data analysis screen will open. (Fig. 23) The system will automatically proceed with recognition of the endothelial cells. After having launched automatic cell count, the operator must verify that the borders identified by the software correspond to the real borders visible on the screen.
Page 26: Toolbar Buttons At The Top Of The Screen
8.12.1 TOOLBAR BUTTONS AT THE TOP OF THE SCREEN BUTTON FUNCTION Prints the processed image. Shows the processed image after editing. Allows the user edit the cells. Modifies the image display parameters. Allows the user to compare two processed images. Shows all the processed images referred to different areas of the endothelium in a single screen.
Page 27: Editing Selected Cells
8.12.2 EDITING SELECTED CELLS To access the cell modification functions, click button or open the menu (Fig.24) and select Edit . Fig. 24 – Editing Menu To view all the areas of the endothelium, scroll the image with the up ↑ and down ↓ keyboard arrows or hold down the left mouse key and drag the image.
Page 28: Editing Image Parameters
8.14 EDITING IMAGE PARAMETERS Click the button to display the unprocessed image of the endothelium in the foreground. To return to the processed image, click the button. Fig. 27 – Image of endothelium Clicking the arrow at the side of the image button opens a menu (Fig.
Page 29: Processing
The Figure 30 functions allow the user to change the contrast, the brightness, and the correction range applicable to the captured image. To eliminate any modifications made, select Fig. 30 – Image parameters 8.15 PROCESSING Fig. 31 – Analysis menu Click the button to process an image.
Page 30: Analysis Results
8.16 ANALYSIS RESULTS The processing window on the right-hand side of the screen displays the graphs and numerical results. The POLYMEGATHISM graph presents the number of cells with surfaces within the highlighted intervals. The PLEOMORPHISM graph presents the percentages of cells having like numbers of sides, corresponding to the scale.
Page 31: Comparison
relative to the part of the cornea captured during the examination. The accuracy of corneal thickness measurement is strictly correlated with the quality of the captured image and for this reason the datum must be considered only indicative and approximate. 8.17 COMPARISON The system allows the user to compare two captures.
Page 32: Overall Comparison Of All The Corneal Areas (Multifix)
8.18 OVERALL COMPARISON OF ALL THE CORNEAL AREAS (Multifix) When images of all the seven possible corneal areas are captured (one central plus six peripheral images), they may all be displayed in a useful summary format called “Multifix.” This function is active even when the acquisitions do not cover all the possible areas.
Page 33: Opening A Patient File In The Archive
8.19 OPENING A PATIENT FILE IN THE ARCHIVE To open the patients list, click the button. To find a particular patient, type the first letter/s of the last name in the command line. (Fig. 38). Only the patients whose last names begin with the letter/s entered will be displayed.
Page 34: Patient Menu Options
8.21 PATIENT MENU OPTIONS Select a patient and right-click. A menu opens. (Fig. 40). Fig. 40 – Edit, delete patient EDIT PATIENT DATA: allows the user to edit the personal patient data. DELETE PATIENT: permanently deletes the patient, as well as all the attached examinations and images, from the archive.
Page 35: Printing
SEND DICOM: allows the user to send an image in DICOM standard protocol. 8.24 PRINTING Printing is possible only if a printer has been connected to the PC. Click the button on the processing screen to open the window shown in Figure 44. UPDATE: allows the user to update the modifications in the print options and view...
Page 36: Dicom
8.25 DICOM DICOM is a medical computer standard, adopted by many health agencies and hospitals in all parts of the world, which permits medical operators to exchange images and other information via computer systems adopting this standard. Deselect the “Suppress DICOM WARNING” box to show any errors that do not interfere with image capture.
Page 37 This window allows the user to identify the PACS system that will receive his information or the PMS system from which information may be requested. In the relative fields, enter: • Title: PACS/PMS ID. • Host: PACS/PMS IP address. • Port: PC port to which PACS/PMS is referred.
Page 38: Operating Features
The endothelial data analyses and the images can be saved in an archive together with the patient’s personal data. This archive may be integrated with the bon software solutions for Corneal Topography and the Digital Slit Lamp.
Page 39: Routine Maintenance
The repairs illustrated below must all be performed only with the power cord disconnected from the line power socket. For any type of trouble requiring repairs different from those described below, contact your installation service. Replacing the line fuses 10.1 REPLACING THE LINE FUSES To replace the line fuses: ...
Page 40: Protecting The Instrument From Dust
10.4 PROTECTING THE INSTRUMENT FROM DUST When the instrument is not in use, it should be covered with the plastic cover supplied as standard equipment to protect it from dust. Any dust that accumulate on the instrument should be periodically removed using a very soft cloth or a rubber ball air blower.
Page 41: Technical Description
0.54 mm x 0.27 mm ±10 µm Measurement accuracy: Video camera: CCD video camera Flash: bon flash tube Illumination for focusing: 12V 30W PG 22 alogen lamp Line voltage: 100V-120V ac ±10% 60 Hz 230V-240V ac ±10% 50 Hz Fuses:...
Page 42: Function Block Diagram
On request, the manufacturer will supply diagrams, components lists, and detailed technical instructions for use only by authorized personnel with prior training in maintenance and calibration. bon Optic hereby declares that all the components making up their instruments are covered by insurance full warranty for 24 (twenty-four) months.
Page 43: Data Plate Symbols
11.3 DATA PLATE SYMBOLS Read the instructions carefully Fuse Type B protection against direct and Mark of compliance with indirect contacts relevant standards Page 42 of 45...
Page 44: Liability
CSO srl assumes responsibility for instrument compliance with European Directive 93/42/EEC and therefore for its performance, safety, and reliability. CSO srl would like to point out that all the components of the devices it produces are covered by insurance and full warranty for 24 (twenty-four) months. CSO srl nevertheless declines said responsibility if: ...
Page 45: Certificates / Statements Of Compliance
CSO srl - Costruzione Strumenti Oftalmici with headquarters in Via Degli Stagnacci 12/e – 50010 – Badia a Settimo – Florence – Italy, manufacturers of the medical electrical system denominated SP/02 Specular Microscope in the persons of its legal representatives Sergio Mura and Giuseppe Matteuzzi, who assume full personal liability for the following, HEREBY CERTIFY ...
Page 46: Reference Standards
The following reference standards were applied in design, production, and testing of the product: EU Directives          D IRECTIVE 93/42/EEC “MEDICAL DEVICES ” of 14 June 1993.          D IRECTIVE 2002/96/EC “Waste Electrical and Electronic Equipment (WEEE).” Standards concerning Quality Management Systems ...