B-SCAN-S User Manual Ver S 1 June 1996

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

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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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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

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8-1 8-2 8-3 8-4 8-6 8-7

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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

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V

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

1-2

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.

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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 :

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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

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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.

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USER MANUAL

2- DESCRIPTION OF THE UNIT

- Biometry Test block location :

Test block

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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

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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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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