User Manual
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USER MANUAL
WARNINGS AND CAUTIONS B.V.I. cannot be held responsible for any damage or injury which results from a failure to follow, or incorrect use of, the instructions contained in this manual. B.V.I. reserve the right to modify the equipment characteristics without previous notice. The guarantee of the equipment will be void if the equipment is opened (even partially), modified or repaired in any way by persons who are not authorised by B.V.I. CAUTION : Federal USA law restricts this device to sale by or on the order of a physician. WARNING : This device is not intended for foetal use : see chapter 11-6. WARNING : Do not use a 3-pin adaptor to accommodate an ungrounded 2-pin wall receptacle. see chapter 1-3 WARNING : Disconnect AC power before cleaning the case : see chapter 2-7 WARNING : Some persons are extremely allergic to isopropyl alcohol : see chapter 2-7 CAUTION : How to prevent patient-to-patient transfer of infection : See chapter 2-8 CAUTION : The B-scan probe and the A-scan probe must be connected (or disconnected) ONLY when the unit is switched OFF. All connectors are key coded to prevent improper installations. Do not force the connectors. CAUTION : The B-SCAN IOL calculator will calculate negative IOL values if such is predicted by the data entered. These are displayed with a minus sign (-). Do not ignore this sign. CAUTION : To preserve the finish of the case, avoid the use of abrasive cleaners. If possible, clean spots before they dry.
Rev. 11/94
I
USER MANUAL
WARNINGS AND CAUTIONS
SERVICE NOTICE : In case of shipment problems, call B.V.International Customer Service : In case of user or equipment problems, call B.V.International Service department :
B.V.International SA 89, Bd Etienne Clémentel 63100 Clermont-Ferrand FRANCE Tel : (33) 73 25 62 27 Fax : (33) 73 25 54 11
To place an order for accessories, call your local distributor
Rev. 11/94
II
USER MANUAL
TABLE
OF
CONTENTS
Pages Warnings Table of contents
I III
1.- INSTALLATION 1-1 Receipt of the instrument 1-2 Packing list 1-3 Power supply 1-4 Mains current and fuses 1-5 Connection of accessories 1-6 Track-Ball installation 1-7 Probe support 1-8 Probe connections
1-1 1-1 1-1 1-2 1-3 1-4 1-6 1-6
2.- DESCRIPTION OF THE UNIT 2-1 General comments 2-1 2-2 Keyboard 2-5 2-3 Probe holder 2-6 2-4 B-scan probe characteristics 2-7 2-5 Standardized A-Scan probe characteristics 2-7 2-6 Care of probes 2-8 2-7 Care of the instrument 2-8 2-8 How to PREVENT patient-to-patient transfer of infection 2-9 3.- STARTING THE UNIT 3-1 Switching on 3-2 Page one 3-3 Date and time setting 3-4 Setup 3-5 How to enter a negative value
3-1 3-2 3-3 3-4 3-5
4.- USER FILE 4-1 Access to the file 4-2 Personalisation of the USER file
4-1 4-2
Rev. 06/96
Rev. 06/96 X
X
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USER MANUAL
TABLE
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CONTENTS
5.- PATIENT FILE 5-1 Accessing Patient file 5-2 Clear all DATA 5-3 Modification of the file
5-1 5-1 5-2
6.- B MODE 6-1 Accessing B mode 6-2 Screen functions available 6-3 B scan image 6-4 B scan image 40 mm 6-5 B scan image + Cross Vector 6-5-1 Axial A-scan vector transfer 6-6 Measuring in B mode : Caliper 6-6-1 Using the Track-Ball for Caliper 6-7 Storing 4 Images 6-8 Recalling the 4 stored images 6-8-1 Automatic Printing of stored images 6-9 Printing B-Scan Images 6-10 Post-processing 6-10-1 Grey levels 6-10-2 Commentary 6-10-3 Markers 6-10-4 AREA measurement
6-1 6-2 6-3 6-4 6-5 6-6 6-7 6-8 6-9 6-10 6-11 6-12 6-13 6-13 6-14 6-15 6-16
X
7.- STANDARDIZED A-SCAN See the special User Manual. 8.- I.O.L. CALCULATIONS 8-1 Accessing calculation page 8-2 Entry of parameters 8-3 Calculation formulae 8-4 Implant constants 8-5 Post operative ametropia 8-6 Printing IOL Calculations
Rev. 06/96
8-1 8-2 8-3 8-4 8-6 8-7
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USER MANUAL
TABLE
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CONTENTS
9.- I.O.L. FORMULAE 9-1 Variables used 9-2 SRK-II 9-3 SRK-T 9-4 BINKHORST-II 9-5 HOLLADAY 9-6 COLENBRANDER / HOFFER
9-1 9-2 9-3 9-4 9-6 9-8
10 - CALIBRATIONS 10-1 Accessing calibration 10-2 Base line horizontality 10-3 Acquisition with test block 10-4 Control of markers 10-5 Calibration procedure 10-6 Last check
10-1 10-1 10-2 10-4 10-5 10-6
11 - SPECIFICATIONS 11-1 Housing materials 11-2 Power entry requirements 11-3 Probe specifications 11-4 Measurement accuracy 11-5 Physiological limits of measurements 11-6 Tissue exposure to ultrasound energy 11-7 Sonic values 11-8 Data entry limits 11-9 Warranty and standards
11-1 11-1 11-2 11-2 11-3 11-4 11-5 11-7 11-8
12 - ACCESSORIES 12-1 Accessories list and codes
12-1
13 - ERROR MESSAGES 13-1 Error messages and corrective actions
13-1
Rev. 06/96
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USER MANUAL
1- INSTALLATION 1-1 RECEIPT OF THE INSTRUMENT
The instrument is delivered in a special shockproof casing. If the instrument has been subjected to low temperature during transport it is not recommended to switch on following unpacking. WARNING : If the instrument is at a temperature close to 0°C, switching ON the instrument may cause serious damage. Unpack the instrument and leave it at normal room temperature for at least half a day to ensure that the internal components warm up gradually.
1-2 PACKING LIST
Before beginning the installation, check the contents of the package against the following list : - B scan instrument - Keyboard - Footswitch - Probe support - B scan probe - STANDARDIZED A-Scan probe - Mains cable - Instruction manuals : * B Mode & General purpose * Standardized A-Scan mode. - Track-ball
1-3 POWER SUPPLY
Voltage 100 -120 - 220 - 240 Volt ~ ± 10 % single phase with earth. Frequency 50 or 60 Hz Power consumption : 200 VA maximum Fuse ratings : 1.25AT at 220/240V~ 2.5 AT at 100/120V~ Note : The symbol "
" means ALTERNATING CURRENT.
Earth Impedence : less than 0.1 Ohm The earth connection should be of low impedence to ensure that the B scan image is of good quality. Poor earth connections will often produce electronic noise superimposed upon the image. Rev. 07/94
1-1
USER MANUAL
1- INSTALLATION 1-4 MAINS CURRENT AND FUSES Main voltage : A mains voltage selector enables the instrument to be adjusted for various supply voltages. Please ensure that the selector is in the correct position for the voltage chosen. Position : 100V ~ suitable for voltages 90V ~ to 115V ~ 120V ~ suitable for voltages 105V ~ to 135V ~ Position : 220V ~ 240V ~
suitable for voltages 195V ~ to 245V ~ suitable for voltages 215V ~ to 265V ~
Body Voltage selection card Voltage indicator
Fuse carrier Cover Fuses
" I " : Switched ON " O " : Switched OFF Fuse carrier Cover Symbol of "Type B"
FUSES : For each voltage selected the fuse value is inscribed on the label plate : Positions : 110V~ or 120V~ Two fuses 2.5 AT Dimensions 5* 20mm Positions : 220V~ or 240V~ Two fuses 1.25 AT Dimensions 5* 20mm "Class 1 " : Accessible conductive parts are connected to earth. "Type B" : Protection against electric shock. Rev. 07/94
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USER MANUAL
1- INSTALLATION 1-5 CONNECTION OF ACCESSORIES
All the accessories are connected to plugs on the rear panel.
THE KEYBOARD AND FOOTSWITCH MUST ALWAYS BE CONNECTED FOR OPERATION.
CAUTION :This symbol is present to oblige the user to consult the accompanying documents before connecting any accessories or options.
CAUTION : Only connect to devices complying with the international standard : IEC 950 for Input and Output signals. 1-5-1- VIDEO OUTPUT : The two BNC are in parallel. For video printer, external monitor or VCR. Composite video signal 1V peak to peak 75 Ohm. 1-5-2- REMOTE PRINTER : Remote video printer control for automatic printing from the B-SCAN. Connector : Standard stereo jack (diameter : 3,5mm). Compatible with SONY UP850, UP860, UP870 models. 1-5-3- TRACK-BALL : Serial port connection for track-ball : SUB-D 9 pin/male connector. The trackball used is specifically the TRACKMAN PORTABLE from LOGITECH. See chapter 1-6- for Trackball installation. Rev. 07/94
1-3
USER MANUAL
1- INSTALLATION 1-5-4- DIGITAL OUTPUT OPTION : For connection to external peripherals. Connector : SUB-D 25 pins Note : This option needs hardware and software options. See specific user manual sheets.
1-6- TRACK-BALL INSTALLATION :
The following parts are provided in the TRACKMAN box : - The TrackMan Portable. - The extension cable. - The attaching device. 1°) Use the extension cable : Plug the male end of the extension cable into the TrackMan Portable's 9-pin connector as shown bellow. Plug the connector in securely and tighten the thumbscrews.
Female end Male end
2°) Connect the TrackMan to the B-SCAN : Connect the female end of the extension cable to the 9-pin connector on the B-SCAN rear panel where the TrackMan symbol is.
Rev. 07/94
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USER MANUAL
1- INSTALLATION 3°) Use the attaching device : Clamp the attaching device onto the side of the keyboard by pressing the button on the attaching device :
4°) Snap TrackMan Portable onto the attaching device :
Rev. 07/94
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USER MANUAL
1- INSTALLATION 5°) How to inverse the forefinger button for left hand use : a) Take out the button as shown bellow :
Button
Side to raise slightly
b) Turn the button and put it back
Button
Rev. 07/94
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USER MANUAL
1- INSTALLATION
c) Inverse the cable direction :
To set the left or right hand use on software, see the chapter 3-4- SETUP file :
Rev. 07/94
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USER MANUAL
1- INSTALLATION 1-7- PROBE MOUNT POSITION : Probe mount fixation for right hand side Probe mount fixation for left hand side
Standardized A-scan Probe carrier B Probe carrier Probe mount
Standardized A-scan Probe B Probe
1-8 PROBE CONNECTIONS Standardized A-scan PROBE : This probe has only one 4 pins LEMO connector as shown above.
Rev. 07/94
B SCAN PROBE : The B scan probe has 2 connectors: 1 - TNC 1 - Black plastic FRB Connect these as shown above. 1-8
USER MANUAL
2- DESCRIPTION OF THE UNIT 2-1 GENERAL COMMENTS The B Scan instrument is a complete echography system which has three basic functions. . B scan echography using a mechanical sector scanning probe. . Standardized A-scan echography for Diagnostic and Biometry . I. O. L. calculation using the 5 most popular formulae. The design of the instrument permits great flexibility of use. - Multiple user choice : -5 independent users can define their individual protocols and parameters and may choose from a list of 8 implants. - The user file stores this information, the name of the user, clinic address etc. and these may be printed out with the Scan results. - All the parameters are safeguarded by a battery driven memory. - The patient file allows patient information to be entered and printed: - Name - Identification - Keratometry readings for both eyes.
B scan Echography : The B scan displays a high definition image on the integrated screen. It has 384 lines of 512 points. Sector angle 50 degrees. There is a standard composite video output available on the rear panel for direct connections to : - Video printer - External monitor - V.C.R. The internal memory allows the storage of 4 images, and these may be recalled individually and reviewed. - Standardized A-scan echography for Diagnostic : Rev. 06/96
2-1
USER MANUAL
2- DESCRIPTION OF THE UNIT The internal memory allows the storage of up to 10 scans for each eye. S-curve amplification to meet Dr OSSOINIG standard. Tissue model to determine tissue sensitivity. 2 points distance measurement. Quantitative-I and quantitative-II amplitude measurements. - Axial length measurements : - Each scan is stored with the measurements for each segment : anterior chamber, lens, vitreous and total axial length. - The page RESULTS shows the mean value of the 10 measurements and calculates the standard deviation for each segment. The acquisition programme is adaptable for all possible cases : - Phakic, aphakic or pseudo phakic eyes - Manual or automatic image freezing - Manual or automatic storage of the 10 scans
- I. O. L. Calculation The calculation page uses : - the axial length chosen from one scan, the average of several scans or a value entered by the operator. - the keratometry measurement from the patient file. Two implant calculations can be seen simultaneously on the screen : - The value for emmetropia - The refraction for 9 implants separated by 0.5 Dioptre bracheted around the closest value for desired post-operative ammetropia. - The implant constants are selected from the user file. - The 5 formulae available are : - SRK-II - SRK-T - HOLLADAY - COLENBRANDER/HOFFER - BINKHORST II - Changing parameters is easy and is followed immediately and automatically by the recalculation of all the values. - Two pages of calculation are held in the memory : one for each eye. Pressing the EYE function changes directly from one page to the other.
Rev. 06/96
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USER MANUAL
2- DESCRIPTION OF THE UNIT - Basic Configuration : Movable probe mount Removable perspex screen
F1 to F4 : 4 software functions displayed on the screen
Keyboard
Track-ball
Green diode ON : Unit switched ON. Orange diode ON : Unit in automatic standby. Red diode ON : Mains Voltage too low.
Rev. 06/96
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USER MANUAL
2- DESCRIPTION OF THE UNIT
- Biometry Test block location :
Test block
Rev. 06/96
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USER MANUAL
2- DESCRIPTION
OF THE UNIT
2-2- KEYBOARD : The keyboard is a 80 keys B.T.C. 5100 "AZERTY" or "QWERTY" . The function keys are used for the basic functions of the unit : GENERAL PRINCIPLE : On each different screen, the 4 functions F1 to F4 are displayed on the lower part of the screen. They act as sub-functions of the BASIC FUNCTIONS which are always accessible with the other keys. Sub functions displayed on the screen
BASIC FUNCTIONS always accessible
Functions valid in B and Biometry
RE-START function : This function allows the user to immediately return to the first page
Example of sub functions in B mode. ZOOM
Rev. 07/94
B + CV
T.G.C.
Caliper
2-5
USER MANUAL
2- DESCRIPTION
OF THE UNIT
2-3- Probe Holder : The probe holder has been designed for easy handling of the probe: - The holder has a rotation axis which brings the probe very close to the patient's head. - The holder is used to support the cable, so the user does not feel any weight or pull. - After the examination, the holder can be moved away from the patient.
Probes on holder Instrument
Probe on patient
Keyboard
Rev. 07/94
Patient
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USER MANUAL
2- DESCRIPTION
OF THE UNIT
2-4 B-PROBE CHARACTERISTICS Type reference : B1 Sector angle = 50° Probe permanently sealed and leakproof Transducer : Frequency = 10 MHz Emission Running mode = Pulsed. Focal length = 24 mm Active diameter = 7.5 mm Active surface = 44 mm² Axial resolution = 0.2 mm (at - 6dB) Lateral resolution = 0.6 mm (at - 6dB)
2-5 STANDARDIZED A-SCAN PROBE CHARACTERISTICS Type reference : STD-A The Standardized A-scan probe is uni-directional. Transducer : Frequency = 8 MHz Emission Running mode = Pulsed. Focal length = Non Focused Active diameter = 5 mm Active surface = 20 mm2 Axial resolution = 0.17 mm (at - 6dB)
Rev. 07/94
2-7