3D/B/A-Scan Ophthalmic Ultrasound
Service Manual
US Federal law restricts this device to use by
or on the order of a physician.
37 Kodiak Crescent, Unit 16
Toronto, Ontario, Canada M3J 3E5
416-631-9123 • 1-888-517-4444
April 2004
COPYRIGHT 2004 OPHTHALMIC TECHNOLOGIES INC. MA-OTISVC-0404
SERVICE MANUAL
Regulatory Notices
U.S. Federal Law requires that this device be used only by or under the
supervision of a physician.
This device has been found to operate within the limits for a Class A digital
device, and is not intended for use in a residential environment.
This is a Class IIa medical device.
Electrical Safety: Class II Type B
Manufacturer:
Ophthalmic Technologies Inc.
37 Kodiak Crescent, Unit 16
Toronto, Ontario, Canada M3J 3E5
416-631-9123 • 1-888-517-4444
European Office:
Ophthalmic Technologies U.K.
University of Kent at Canterbury
School of Physical Sciences
Room 41
Canterbury, CT2 7NR
United Kingdom
Tel.: 44-1227 824 279
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SERVICE MANUAL
Warranty Information
Ophthalmic Technologies, Inc. (OTI) warrants its products are free of defects of
labour and material for two years for electronics, 1 year for probes. Associated
computer systems carry a 1 year manufacturers warranty; extended warranties are
optionally available.
The following items are not covered:
Physical damage to the unit or probes due to misuse or shock
Damage or data loss due to power failures or fluctuations. The use of a line-
interactive UPS is recommended to avoid this type of failure.
Loss or corruption of data or software due to user error or the installation or use of
any third-party hardware or software.
Damage to transducers caused by autoclaving or exposure to excessive heat.
Repairs not covered by warranty will be invoiced on the basis of parts and labour.
At OTI’s discretion, the damaged component may be exchanged at a flat rate.
Networking
OTI does not provide support for the operation of its products in a network
environment. Connection to and operation on any network is entirely the
responsibility of the user. Where installation or use of any network hardware or
software interferes with the normal operation of the OTI product, that product must
be returned to normal operation at the user’s expense. When the connection of an
OTI product to, or installation of OTI-supplied software on, a network interferes
with the operation of the network, the product must be removed from the network;
alternatively, the problem may be resolved by the user in cooperation with the
network owner, at their expense.
Third-Party Software
OTI does not provide support for the use or installation of any software obtained
from a third party on its products, including, but not limited to, operating system
upgrades and device drivers. When software not supplied by OTI interferes with the
operation of the system, the product will be returned to its original condition at the
user’s expense.
OTI may occasionally furnish to users software not directly related to the
functioning of its products. Such software is supplied as is, without warranty of any
kind, and the availability of support for such software is at OTI’s sole discretion.
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SERVICE MANUAL
Warnings and Cautions
WARNING:
Switching on a cold instrument near 0° Celsius will permanently damage it.
Let the instrument reach a normal room temperature for half a day to allow the
internal elements to warm up and to avoid any thermal shock hazards when
switched on. The cover will quickly reach room temperature, but not the internal
circuitry.
WARNING:
Unit is approved for operation only with the included power supply.
Warning:
Disconnect AC POWER before cleaning the case
Warning:
The transducers are fragile. Dropping or striking any probe can cause it to
malfunction. Handle all probes with care. If a probe should be dropped, inspect it
carefully for chips and cracks, and make a test scan on a known object.
Warning:
This device is not intended for foetal use.
Caution
The console must not be disconnected from the computer while the system is
running.
Caution:
The probe must be connected or disconnected only when the unit is switched OFF .
Warning:
Never autoclave a transducer or expose it to high heat.
Caution:
Follow the instructions included in this manual for disinfecting the transducer after
each use.
Caution:
Applying excessive pressure to the probe will cause discomfort for the patient and
distort the eye, resulting in incorrect measurements.
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SERVICE MANUAL
INTRODUCTION
OTI-Scan V5.0
This Service Manual describes the OTI-Scan B, A and 3D system hardware and
software.
This page is a brief outline of the entire system. The functions described will not be
available on every system: the selection depends on the system configuration.
The software uses a tabbed interface: the user can select any of the primary
functional modules at any time by clicking on the tab for that function at the top of
the screen. When there are several major components in a function, these are
presented as tabs below the principal tab bar.
The opening screen is generally the Patient data screen. The operator is not required
to identify the patient before starting the examination; this can be done at any time
during the exam, and, if no patient has been selected when "Save" is clicked, the
operator is automatically taken into the database to select the appropriate patient
record or create a new one. Warning: the same patient will be used for all saves until
another has been selected.
The patient information screen has been organised to display full information and a
list of saved examinations for the selected patient, summary information about the
images is displayed, including any notes on probe orientation that were recorded at
the time the image was captured and saved. When an exam is selected, a simplified
view is presented, so that the user can review it. It is possible to copy and delete
saved examinations one at a time.
The printing system has been designed to use the default printer and provide access
to the control functions available from the printer drivers. Curves are printed in
black on white, reducing ink consumption.
There are no field-serviceable components in the system, other than the footswitch,
and all preventive maintenance can be performed by the end user. Service action is
limited to identifying components for replacement or upgrade.
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SERVICE MANUAL
Chapter 1
Characteristics
1 Description
The OTI - Scan ultrasound system is an ultrasonic diagnostic system intended to be
used for ophthalmic applications.
Scans can be made in immersion mode or by placing the probe directly on the eye.
The OTI-Scan software runs on Apple MacOS, and uses the features of the MacOS
interface to direct the operation of the system and maintain patient records,
permitting a user-friendly environment for clinical applications.
2 System components
The OTI-Scan system consists of the OTI -Scan ultrasound unit, which contains the
ultrasonic pulser/receiver and scan converter, and an attached computer for control,
patient data storage and calculations. It includes a focussed B-scan/3D-scan probe
operating at 12MHz and, a focussed biometry probe operating at 13 MHz. A
diagnostic A scan probe is available as an option.
3 Application
To make a measurement, the operator first displays the acquisition screen, and
follows the instructions for its various controls. The probe is applied to the patient’s
eye directly or using an immersion cup. For biometry, there are two modes of
operation, automatic and manual. In automatic mode the system identifies the
critical structures in the eye and makes the measurements. In manual operation the
operator must freeze an image and then select the points for the measurements.
There are optional settings for particular cases such as dense cataracts or silicone
filled eyes.
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SERVICE MANUAL
4 Specifications
a. Dimensions
i. 165 x 93 x 188 mm
ii. weight: 0.8kg
b. Materials
i. B probe – body: anodised aluminium; membrane: TPX
ii. Biometry Probe – body: GE Noryl EN265; membrane: Master
Bond EP21LV
iii. Housing – ABS, UL 94 V0
c. Power Supply
Elpac Power Systems model MW-4012
i. Input Voltage range: 100-240V AC
ii. Output Voltage: 12V DC
iii. Frequency: 50/60Hz
iv. AC power consumption: 10VA @ 120V
v. DC power consumption: 4.2W
d. Operating conditions
i. Temperature:
ii. Operating = 19 degrees to 35 degrees C (32 to 95 F);
iii. Storage= -40 to 65 C (-40 to 149 F)
iv. Relative humidity:
v. Operating = 10% to 90% (non-condensing);
vi. Storage: 5% to 95% (non-condensing)
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e. 3D reconstruction
i. Scan time: 1.95 or 3.9 seconds
ii. Angular resolution: < 2°
iii. Capture depth: 40mm
iv. Display resolution: 0.1mm on each axis
f. Probes
i. Biometry
1. Reference: US-PRO-A
2. Frequency: 13MHz
3. Focal Length: 23mm
4. Operating mode: Pulsed
5. PRF: 10Hz
6. Active diameter: 3.5mm
7. Active surface: 9.6mm2
8. Axial resolution: 0.12mm
9. Minimum distance measured: 12mm
10. Maximum distance measured: 37mm
11. Acquisition
i. Horizontal resolution: 700 points
ii. Vertical resolution: 256 points
iii. Linear resolution: 0.052mm
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12. Accuracy
i. Measurement accuracy is limited by the technique
employed. Maximum 0.12mm, assuming no errors
in technique
ii. IOL powers are displayed in increments of .25D,
with refractive errors estimated to .01D. For SRK II,
a .2mm error in axial length yields a .5D error in
calculated refraction; for other formulas, a .5D error
corresponds to a .15mm error in the axial length.
ii. B Scan
1. Reference: US-PRO-B
2. Frequency: 12MHz
3. Focal Length: 23mm
4. Operating mode: Pulsed
5. PRF: 15625Hz
6. Active diameter: 7mm
7. Active surface: 154mm2
8. Axial resolution: 0.12mm
9. Acquisition
i. Horizontal resolution: 1024 points max
ii. Vertical resolution: 256 lines
iii. Linear resolution: 0.052mm
10. Accuracy
Measurement accuracy is limited by the technique
employed. Maximum 0.12mm, assuming no errors in
technique
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SERVICE MANUAL
iii. ALARA SECTION AND EMISSIONS
ALARA SECTION
(As Low as Reasonably Possible)
The energy will always be attenuated by the tissue between the transducer and the
focus when used as recommended. The values presented here are the values at the
focal point, the point of maximum intensity.
It is not possible to vary the output energy of the transducer. However, to minimize
exposure, measurements should be kept as short as possible.
If more accuracy is desired, the intensity in the body at any transducer point may be
calculated according to the formula recommended by the FDA:
It = Iwexp(-0.069fz),
where It = is the estimated in situ intensity, Iw is the measured intensity in water at
the focus of the transducer (indicated in the chart below), f is the ultrasonic
frequency in megahertz, and z is the distance from the face of the probe to the
transducer focus in centimeters, which is the point of measurement. This formula
was also used to calculate the derated values shown below.
Transducer parameters show considerable variation from transducer to
transducer. The measured and calculated values shown above were those for an
actual transducer, whose values deviated slightly from the values in the
specification above, and whose values are likely to be different from the transducer
with your system. However, the values in the specification should give results that
are accurate enough for any practical purpose, since the intensities are very low.
One should always minimize exposure by limiting the ultrasonic
transmission to as short periods as possible.
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SERVICE MANUAL
Global Maxima:
Accuracy
The system measurements have an accuracy of .12mm This does not include errors
caused by operator technique or uncertainty in the velocity of sound. This accuracy
can be expected over a range of 12 to 37 mm of axial length.
Velocity of sound used by system: (values for different eyes)
Aqueous 1532
Vitreous 1532
Silicone Oil 990
Natural lens 1641
Silicone IOL 980
PMMA IOL 2718
Acrylic IOL 2120
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STANDARD SYMBOLS
Attention, consult accompanying documents.
Dangerous voltage
Symbol type BF equipment
Accessible conductive parts are connected to earth
Equipotential point
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SERVICE MANUAL
5 DESCRIPTION and CONNECTIONS
A. FRONT PANEL
Optical Encoder for
Multi-function control knob:
Gain, Dynamic, TGC
A Probe
B Probe
B. Rear panel
On/Off
Footswitch Power
Firewire port
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SERVICE MANUAL
C. Internal Connections
Top view of
chassis showing
board positions
and internal
Main Board
wiring.
Frame Grabber Board
40-pin Ribbon Cable,
connecting Main
Board to Frame
Frame Grabber
digitizes video from Main Board and
Ultrasound Main Board provides Serial to Firewire conversion
generates and provides all
ultrasound functions
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SERVICE MANUAL
D. Probes and accessories
B probe
A/Biometry probe
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Power supply
Footswitch
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Chapter 2
Set-up and Maintenance
1. Setup
A. INSTALLATION
a. Place OTI-Scan and computer on a flat surface. Position the system to
ensure
that the operator will be comfortable during use
b. Connect power supply to OTI-Scan and AC power. Connect computer
to
AC power
c. Connect Firewire cable to OTI-Scan and computer
d. Connect all probes
e. Switch on the OTI-Scan, then switch on the computer
f. Install and connect printer in accordance with manufacturer’s
instructions
g. If the OTI-Scan software is not pre-installed, install following directions
provided with the software CD
B. VENTILATION
Like other electronic equipment, the OTI-Scan produces heat, which must
be exhausted for correct system operation. Keep the unit away from walls to
allow air circulation and never cover the unit even partially (with protective
cover, files etc.) during use. It is particularly easy for laptop computers to
overheat when used in confined spaces.
C. PRINTERS
The OTI-Scan is designed to use standard Macintosh printers (the printer
must be MacOS X compatible). Print speed and quality will depend on the
printer chosen. In general, the printer is not supplied. OTI only offers limited
assistance with the installation of printers.
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SERVICE MANUAL
Printer Installation
All printers should be installed according to the directions in the user’s
manual supplied with the printer, using the correct MacOS X drivers.
Drivers and driver installers for a limited selection of printers may be pre-
loaded on the OTI-Scan.
2. Maintenance
Maintenance consists of regular cleaning of the equipment and disinfection
of the probes. This must be performed by the user regularly as required by
infectious control protocols.
Routine performance checks are done by the user on a daily basis, following
the instructions provided in the User Manual.
Cleaning
Clean the case with a damp cloth. Use appropriate products to clean the
computer, keyboard and monitor. Cables may be cleaned with a soft cloth
and alcohol.
Dust should be removed from the footswitch as often as local conditions
require. If needed, the footswitch should be opened for cleaning, using
simple tools.
The probe holder should be washed with warm water and a mild detergent
to prevent build-up of gel.
Disinfection
The probe must be cleaned and disinfected between patients to prevent the
transmission of infections. It is the user’s responsibility to ensure that the
relevant standards are maintained and that the products and procedures are
effective and appropriate for ophthalmic applications. Instructions are
provided in the user manual. The information is supplied for the guidance
of users, and specific products are mentioned for illustration only; OTI does
not endorse the use of these or any other product. Products must be used in
accordance with the manufacturer’s instructions.
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SERVICE MANUAL
Chapter 3
Troubleshooting
A. Hardware
Other than the footswitch, the hardware includes no field-serviceable components.
Any unauthorised repairs will void the warranty and make the equipment ineligible
for standard-exchange parts replacement.
Console: If ultrasound image is not displayed on the screen, and you have verified
that the firewire cable is functioning properly, replace the entire console.
Alternatively, you may replace the Frame Grabber and/or the Main Board to
determine which of these two key components is defective.
Note: Consoles are pre-programmed and calibrated at the factory. When consoles
and/or probes are exchanged, the calibration files must be updated by running the
factory-supplied installer CD.
Footswitch: If the system operates correctly, but doesn’t respond to the footswitch,
the footswitch may be opened, checked for continuity and repaired by any
technician. No special equipment is required.
Cables: The interconnection between the console and the computer uses a standard
IEEE1394 FireWire cable. If there is a problem with communication between the two
components, the cable and connections should be checked. If needed, the cable may
be replaced with a good-quality IEEE1394 cable; it is preferable that the cable be the
shortest available.
Power Supply: To ensure patient safety, the console power supply and, if used,
computer isolation transformer must be replaced with IEC/EN 60601-1 certified
components.
Computer: The computers used with the OTI Scan are standard Apple products.
Servicing may be referred to the nearest Apple Authorized Service Center.
All other hardware problems must be referred to OTI or your local distributor for
diagnosis and repair. Faults are normally resolved by the exchange of the failed unit.
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SERVICE MANUAL
B. Software
To close the OTI Scan software and go to the Macintosh Desktop, press Apple and
Q keys simultaneously. To restart the software, click on the OTI Scan “eye” icon in the
Dock. The ‘Apple’ keys are located beside the space bar on the Apple keyboard.
Note: This should be done only if required for system maintenance. Running other software
on the system can prevent it from operating correctly.
“Required Resources” message: There is a known issue with corruption of the
PatientIni file, due to errors in library software supplied with Mac OS. If a message
is displayed indicating that the software can’t locate required resources, follow the
steps below.
1. Return to the Desktop, if not already there.
2. Open the Go menu, and click on Home.
3. Open the Library folder in the Home window and scroll down to find the file; drag it to the Trash
and close all the windows.
4. Restart the OTI Scan software; it will tell you that it needs to locate the Patient Data folder. Click
OK. The Locate File dialog will open, and it will probably be pointing to the previous folder.
5. Use the scroll bar at the bottom of the dialog to scroll left until you see the User list; there will be
one folder called Shared and one labelled with the serial number of the system. Click on Shared,
then on Patient Data. Click OK.
6. Any user modifications to the default settings will have to be restored manually, as they are
included in this file.
Program crashes when Utilities tab clicked: The software expects to find a blank
CD-R in the drive when the Archive function is started. If there is a non-writable
disk in the drive when Utilities is selected and Archiving is available, it may shut
down instead of displaying an error message. Remove the disk from the drive and
restart the software.
Repair: The simplest way to correct other software problems is to reinstall using the
CD supplied with the system. The installer can be run as follows:
1. Start up the system.
2. Return to the Desktop by pressing Apple + Q.
3. Insert installer CD; open CD by double clicking on the CD icon.
4. Double click OTI installer.
5. Follow the on-screen instructions. When asked for a password, leave it blank (unless you
entered a password when you set up your own system) and click “OK”.
6. Eject the CD by dragging the icon to the trash. (Note that the trash icon will change to an eject
icon.)
7. Click the OTI scan icon from the dock and start the program.
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SERVICE MANUAL
Note: To prevent communication errors, software upgrades and re-registrations will
not be done by phone.
Upgrades: OTI Scan software upgrades and fixes will be furnished by OTI on CD.
The software can also check for upgrades on command and install them
automatically, if the system is connected to the Internet. Upgrades on CD can be
installed following the above instructions. If a configuration upgrade has been
purchased from OTI, a new software registration code will be supplied. It can be
installed as follows:
1. Return to the desktop,
2. Start the software while holding the Option key.
3. The dialog below will appear. Enter the registration code. Note that it is case-sensitive, and
must be entered as it supplied.
Software reinstallation: If the computer must be repaired or reformatted, the
software can be reinstalled from the original CD plus any update CDs that have
been received. When first run, it will request the registration code. The original
registration code should be recovered, from the file in the Home::Documents folder
[see above for instructions on locating Home] named with the serial number of the
system, before repair. If it can’t be recovered, or the motherboard or entire computer
must be replaced, contact OTI by e-mail or fax, giving the system serial number and
software serial number, exactly as displayed. If the unit is shut down, and restarts in
a null condition, follow the upgrade instructions above to enter the registration code
when received.
Mac OS X: MacOS upgrades should never be installed without permission of OTI.
We cannot guarantee that the software supplied with the unit will run correctly with
future versions of MacOS.
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