Siemens TS2000 User manual

TS2000
TransSpectral Impedance Scanning
RD7409290-0 Revision F
Service Manual
SPB7-520.840.01.01.02

SPB7-520.840.01.01.02

TS2000 Service Manual
Copyright© 2001 Transscan Ltd.
RD7409290-0 Rev. F
Name Signature Date
Prepared By Dov Alkopher
Checked By ThiloAm-Ende
Approved By Yoav
Wimisner
Quality Assurance Ora Peri
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Table of Contents
1. WARNINGS AND PRECAAUTIONS........................................1-1
1.1 Symbol Descriptions..................................................................1-2
2. FUNCTIONAL DESCRIPTION ...............................................2-1
2.1 Introduction................................................................................2-1
2.1.1 Principle...........................................................................2-1
2.1.2 Main features:................................................................... 2-2
2.1.3 Comparison with Other Methods of Breast Examination..2-3
2.1.4 Included in this Package ...................................................2-4
2.2 System Overview....................................................................... 2-5
2.3 Block Diagrams (1 and 2)..........................................................2-6
2.4 General System Work Flow .......................................................2-7
2.5 Monitor......................................................................................2-7
2.6 Keyboard and Mouse.................................................................2-7
2.7 Main System Console.................................................................2-7
2.8 Computer Base (PC) ..................................................................2-7
2.9 CD-ROM Drive .........................................................................2-8
2.10 Modem (TeleService Package—Up to Serial # 2087)...............2-8
2.11 Zip Drive.................................................................................... 2-8
2.12 Printer (Optional)....................................................................... 2-8
2.13 Processing Module (PM) ........................................................... 2-8
2.14 Probe Control Unit.....................................................................2-9
2.15 Reference Signal Generator..................................................... 2-10
2.16 Probe Selection Board (PSB) Overview .................................2-10
2.17 Scan Probes (Small Probe, Large Probe).................................2-11
2.18 Probe Scan Arrays of............................................................... 2-11
2.19 Transmitter (Reference) Cylinder ............................................2-11
2.20 Software Overview..................................................................2-12
3. INSTALLATION OF OPTIONS...............................................3-1
3.1System Setup .............................................................................. 3-1
3.2 Laser Printer (Optional).............................................................3-1
3.2.1 Set up the Laser printer:.................................................... 3-1
3.2.2 Print Resolution Adjustment .............................................3-2
3.3 Modem (Until Serial # 2086).....................................................3-2
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3.3.1 General.............................................................................3-2
3.3.2 Change from ANALOG to ISDN ......................................3-2
3.3.3 Change from ISDN to ANALOG ......................................3-3
3.3.4 Verifying Operation.......................................................... 3-4
3.4 Internal Zip Drive (Atapi Model)............................................... 3-4
3.4.1 Hardware Installation.......................................................3-4
3.4.2 Installation of Zip Drive Software.................................... 3-4
4. SOFTWARE INSTALLATION and UPGRADE......................... 4-1
4.1 Verifying the Actual Software Version....................................... 4-1
4.2 Full Software Installations ......................................................... 4-1
4.2.3 Installation Procedure.......................................................4-2
4.2.4 Formatting the Hard Drive................................................4-2
4.3 Upgrade of TS2000 Software..................................................... 4-3
4.4 Additional Software Installation................................................4-3
4.4.1 WIN NT4 Installation (Including Service Pack 4)............ 4-3
4.4.2 Installation of VGA Driver............................................... 4-5
4.4.3 Installation of Printer Driver ............................................ 4-5
4.4.4 PcAnywhere Installation................................................... 4-6
4.4.5 Zip Drive Software installation........................................ 4-7
4.4.6 Installation of ODBC Software.........................................4-7
4.4.7 Installation of I/O Card Software..................................... 4-8
4.4.8 Installation of Port ID Driver Software............................ 4-8
4.4.9 Installation of Autolog Driver Software ........................... 4-8
4.4.10 Software Installation.......................................................4-9
4.4.11 Changing Keyboard Language.........................................4-9
4.4.12 System Software Installation.......................................... 4-9
5. PARTS REPLACEMENT ....................................................... 5-1
5.1 Replacing the Computer ............................................................. 5-1
5.2 Replacing the PM Board............................................................ 5-3
5.3 Replacing the PSB Board (Mounted) .........................................5-4
5.4 Replacing the Isolated I/O card.................................................. 5-4
5.4.1 Replacing Card.................................................................5-4
5.4.2 Jumpers on the I/O Isolation Card.................................... 5-5
5.5 Replacing the Parallel Communication Card..............................5-5
5.6 Replacing the Scan Probes......................................................... 5-5
5.7 Spare Parts List.......................................................................... 5-6
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6. TROUBLESHOOTING ..........................................................6-1
6.1 Error Messages.......................................................................... 6-1
6.1.1 Displayed Error Messages ...............................................6-1
6.1.2 TransScan TS 2000 Error Message..................................6-2
6.1.3 Windows NT Error Messages.......................................... 6-3
6.2 Input/Output Problems................................................................6-3
6.3 Port Setup...................................................................................6-5
6.4 PM and PSB TESTS ..................................................................6-6
6.4.1 Preparation....................................................................... 6-6
6.4.2 Serial Communication Test...............................................6-6
6.4.3 Check for the P.S.B: Socket (port I.D.).............................6-6
6.4.4 Probe I.D. Test.................................................................6-7
6.4.5 ACQ Test (Parallel Communication Test)........................ 6-7
6.4.6 Picture Uniformity, Tested with the Help of the System
Phantom......................................................................................6-7
6.4.7 Check PM Output..............................................................6-7
6.4.8 Verify Parallel Communication........................................6-7
6.4.9 PM Board.........................................................................6-8
6.4.10 PSB Board......................................................................6-9
7. MAINTENANCE....................................................................7-1
7.1 Phantom Check...........................................................................7-1
7.2 Monitor Check List.....................................................................7-1
7.3 Printer “Self Test”......................................................................7-1
7.4 Functional Tests.........................................................................7-2
8. APPENDIX............................................................................8-1
8.1 Detailed Hardware Platform Specifications ..............................8-1
8.2 Figures .......................................................................................8-3
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Tables of Figures
Figure 2-1: Complete TS2000 System in Cart (Front View) .....................................2-5
Figure 2-2: TS2000 System Block Diagram............................................................2-6
Figure 2-3: System Block Diagram ........................................................................2-6
Figure 2-4 Processing Module-Block Diagram........................................................2-9
Figure 2-5 Probe Control Unit Block Diagram........................................................2-9
Figure 2-6: Reference Signal Generator Block Diagram.........................................2-10
Figure 8.2.2: Overhead view.................................................................................8-4
Figure 8.2.3: TSP Power Connection 230 VAC......................................................8-5
Figure 8.2.4: TSP Power Connection 115VAC .......................................................8-6
Figure 8-5 Cable Locations...................................................................................8-7
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1. WARNINGS & PRECAUTIONS
WARNING:
!
Installation and servicing should be undertaken
ONLY by qualified service personnel. In order to
prevent electrical shock; do not remove covers or
panels. This equipment should be used ONLY in
accordance with instructions for use
CAUTION:
In the event of defective functioning of TS2000,
contact the relevant Siemens service department.
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1.1 Symbol Descriptions
Attention: Consult accompanying documents
οο
Off: Power disconnection from the mains
 On: Power connection to the mains
NOTE:
The CE 0344 mark for this device can be found on the left side of
the central processor.
This device complies with MDD Regulation 93/42/EEC.
Symbols Description
Type BF equipment
Dangerous voltage
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2. FUNCTIONAL DESCRIPTION
NOTE:
This Document applies to TS2000 systems from serial no.
02001
2.1 Introduction
2.1.1 Principle
Tissue changes associated with cancer cause significant changes in
local dielectric properties of tissue. These dramatic shifts in electrical
impedance result from cytological and histological changes involving
cellular water content, amount of extra-cellular fluid, membrane
properties and packing density and orientation of cells that are typical
of malignant tissue transformation.
The electrical impedance (both conductance and capacitance) of
malignant tissue is typically 20-40 times lower than that of normal
tissue when measured at appropriate frequencies.
TransSpectral Impedance Scanning (TS2000) detects cancerous
changes in the breast by providing a real-time, two-dimensional visual
display of local variations in tissue electrical conductance and
capacitance. Changes in tissue electrical conductance and capacitance
associated with malignancy result in a characteristic signature that can
be readily identified in the TS2000 image.
TS2000’s unique potential to distinguish and detect early signs of
cancer is based upon detecting these electrical changes non-invasively.
TS2000 (Trans-Spectral Impedance Scanning) is a unique system
designed specifically for non-invasive, accurate detection of early
stage breast cancer.
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2.1.2 Main features:
•Increased accuracy in the detection of early breast cancer
•Real-time impedance imaging with improved frequency
range
•Increased measurement resolution
•Identification of tissue variation location (based on
sectors)
•Non-invasive technique
•Safe method of detection -presenting no significant risk
to patient or operator
•Patient experiences no discomfort or sensation during
procedure
•More affordable system and examination costs
•Minimal training required for the operator
•Age not an inhibiting factor inthe accuracy of the results
(works well in younger women with dense breast tissue)
TS2000 provides a real-time, two-dimensional visual display of local
variations in tissue electrical conductance and capacitance. Tissue
changes associated with cancer cause a significant change in local
dielectric properties. In the human breast, the electric impedance
(conductance and capacitance) of cancerous tissue is typically 20-40
times lower than in normal tissue when measured at appropriate
frequencies. The dramatic changes in electrical impedance stem from
cytological and histological changes that relate to the cellular water
content, the amount of intracellular fluid, membrane properties, the
packing density and orientation of the cells. These changes in the
electrical impedance of the cancerous tissue can be visualized and
identified using the T-Scan system.
Similar, though less dramatic changes are also seen in pre-cancerous
abnormal conditions such as atypical hyperplasia, giving T-Scan a
potential role in identifying high-risk patients before cancer develops.
The system utilizes a non-invasive approach. A probe is gently
pressed against the breast to measure low-level electrical currents
generated across a spectrum of frequencies by an electrode held in the
patient’s hand. The T-Scan image that is produced is divided into
sectors allowing for immediate location identification and
measurement of any tissue variations.
TS2000 is safe! The T-Scan method of detection is non-invasive, uses
no radiation and complies with electrical safety standards. The system
uses low voltages and currents for measurement, which cause no
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discomfort or sensation. Since the system does not use radiation, it
allows for more frequent and consistent monitoring of the patient
condition. Over a twelve-year period (with the original prototype
device) and 16,000 clinical examinations, there were no reports of
harm or adverse side affects to the patient or the operator.
TS2000uses a totally different method of detecting breast disease than
mammography, combining the results of T-Scan with those of
mammography may increase the overall sensitivity and/or specificity.
Similarly, by combining the results of T-Scan with the Clinical Breast
Exam, the diagnostic accuracy of the CBE as performed by primary
care physicians should be dramatically improved and quantified for
more reliable pre-mammographic screening. The overall outcome of
using the T-Scan system should reduce the rate of missed tumors and
unnecessary biopsies, and their associated financial and emotional
costs.
2.1.3 Comparison with Other Methods of Breast
Examination
NOTE:
TS2000 should always be used in conjunction with
other methods of breast examination (CBE,
mammography, ultrasound) and not as a stand-alone
device.
Mammography detects breast disorders by using radiation to identify
variation in tissue density. In contrast, TS2000uses no ionizing
radiation and detects changes in electrical impedance. Because
TS2000uses a totally different method of detecting breast disease than
mammography, combining the results of TS2000 with those of
mammography may increase overall sensitivity and/or specificity of
diagnosis.
Similarly, pre-mammographic screening by means of clinical breast
exam (CBE) can be made more accurate when CBE is used in
conjunction with T-Scan.
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2.1.4 Included in this Package
•TS2000 Main Module
•Cart
•Monitor
•Mouse
•Keyboard
•1 Scan probe –64 sensors
•1 Scan probe –256 sensors
•Transmitter Cylinder
•Transmitter Cable
•Set of CDs including:
•Windows NT4 and Service Pack 4
•TransScan Software
•Printer, VGA, and Zip Drive software
•Application software
•Isolation transformer for Printer
•Zip Drive
•Modem (Up to and including serial number 2086,
thereafter, the modem is an option.)
•Printer (Optional)
•TransScan TS2000 Manual
•Quality Assurance Kit (optional) including:
•Service Phantom
•Transmitter Cable X2
•Five fuses rated at 4 A/230V
•Five fuses rated at .5 A/230V
•Five fuses rated at 6.3A/115V
•Five fuses rated at .5 A/115V
•Zip Diskette
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2.2 System Overview
The TS2000 is housed in a sturdy, portable storage cart and comprised
of the following elements (refer to Figure 2-1):
•Monitor
•Main System Console: Computer Base; Processing
Module (PM),
•Probe Selection Board (PSB)
•Keyboard and mouse
•Transmitter (reference) cylinder
•2 Scan (receiver) Probes: Large(Standard),
Small(Optional)
•Printer (optional), Modem (optional), and Zip Drive
Figure 2-1: Complete TS2000 System in Cart (Front View)
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2.3 Block Diagrams (1 and 2)
Figure 2-2: TS2000 System Block Diagram
Figure 2-3: System Block Diagram
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2.4 General System Work Flow
When a scan is performed, the system sends an electrical current through the
transmitter cable into the hand-held cylinder. The current then flows through
the patient's body and is detected by the scan probe. The current is then
picked up by the scan probe. The current picked up by the scan probe is sent
to the TransScan systemthat determines the changes in the electrical
impedance. The output is then displayed on system monitor.
2.5 Monitor
The monitor specifications are as follows: 17 inch super VGA, 640 ×
480. The monitor provides the display of the user interface, including
all patient data entries and their resulting T-Scan images.
2.6 Keyboard and Mouse
The keyboard and mouse are standard PC compatible devices that are
used by the TS2000 for system operation and data entry.
2.7 Main System Console
The Main System Console is comprised of the Computer Base (PC),
the Processing Module (PM) and the Probe Selection Board (P.S.B.).
2.8 Computer Base (PC)
The Computer base is a PC with the following configuration:
•Intel Celleron A300 MHz (or better) with 256 kb EXT.
cache, or equivalent CPU
•32 MB RAM
•6.4 GB hard disk, or larger
•AGP VGA adapter
•1.44 MB floppy disk (optional)
•CD-ROM drive
•ZIP Drive
The PC platform has a medical grade requirement, which refers to the
ability of the PC power supply to meet the AC mains leakage current
requirements.
The Computer Base is the master controller of the system. It is
responsible for the user interface, real-time acquisition, processing and
display of the sensor data sampled by the Processing Module, as well
as database archiving and replay, hard copy, and communications.
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2.9 CD-ROM Drive
The CD-ROM is used to load software to the system.
2.10 Modem (TeleService Package—Up to Serial # 2087)
A modem is included in all units up to serial number 2087.
Use the modem for “Remote-Diagnostic” of the system, through a
standard telephone line. The Modem can be an ANALOG or ISDN
type.
The remote diagnostic option can be used for data transfer, operational
problem-solving and remote consultation.
2.11 Zip Drive
The internal zip drive is used to archive data from the system. Each
zip diskette can store more than 100 patients.
2.12 Printer (Optional)
The printer specifications are as follows: IBM LEXMARK model
OPTRA K 1220 (1200dpi), or equivalent. The printer allows for
immediate hard copy viewing of the T-Scan image for the purpose of
diagnosis and/or referral.
2.13 Processing Module (PM)
The Processing Module (PM) consists of a card housed in a case
above the computer. Located in the back of the PM is the connection
panel, which links the PM to the Transmitter cylinder and the PSB.
This unit contains the analog processing electronics, and the reference
signal generator. This unit also includes a suitable power supply for
operation of the PM. This unit includes interfaces and connectors to
standard PC compatible serial ports, and a special parallel interface
board.
The Computer Base controls the PM. It generates reference signal
waveforms for transmission through the body, acquires and pre-
processes the sampled signals from the probe sensor arrays and then
transmits them to the computer via a parallel communication interface
port and through high-speed (115.2 Baud) RS232 link. The PM also
limits the current of the applied signals for safety of the patient, and
medically isolates the patient from ground.
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Figure 2-4Processing Module-Block Diagram
2.14 Probe Control Unit
The Probe Control Unit consists of:
•CPU
•RAM configurable as 32 KB ×16 or 128 KB ×16
•Flash ROM of 128 KB ×8
•Reset Circuit
•14.7 MHz Crystal Oscillator
•PC Serial Interface
•Local I/O Interface
•PC Parallel interface
MPU Optical
Coupling RS-232 Drivers
14.7 mHz
RAM FLASH
PC COM
Local I/O
Figure 2-5Probe Control Unit Block Diagram
The CPU boots after reset from the flash memory and continues by
running some POST (Power On Self-Test) diagnostics. In addition to
the POST software, the flash ROM also contains communication and
flash programming software, as well as probe specific parameters.
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Acquisition and interrupt handling software is loaded to the RAM
before execution, in order to attain maximum performance.
2.15 Reference Signal Generator
The Reference Signal Generator (RSG) consists of the following
blocks:
•A Programmable Sine Wave Generator
•A Programmable Gain Amplifier
Safety
Switch
Figure 2-6: Reference Signal Generator Block Diagram
The CPU controls the RSG in order to produce the required frequency
and amplitude during an acquisition cycle.
2.16 Probe Selection Board (PSB) Overview
The purpose of the PSB is to enable the operator to work
simultaneously with up to three probes. Currently the system is
supplied with two probes, large and small. The probes are connected
all the time, and by pressing the “GO” button on one of them the system
selects the probe, and connects its data lines to the PM board.
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