Esaote Falco [PDF]

Zitiervorschau

Service Manual 100 Falco

ART # 410545 DOC # 53B43SM03

DOC # 53B43SM03

Pie Medical Equipment

Copyright © Pie Medical Equipment B.V.. All rights reserved. Reproduction in whole or in part is prohibited without the written consent of the copyright owner. Use of the information contained herein in any form and/or by any means whatsoever is strictly reserved for Pie Medical Equipment B.V. and its licensees. Use of this manual by unauthorized is strictly prohibited. DOC # 53B43SM03

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Introduction ............................................................................................................1 1.1 About this manual ...........................................................................................1 1.2 The 100 Falco.................................................................................................1 1.3 Warnings and Precautions .............................................................................2 1.3.1 Warnings .................................................................................................2 1.3.2 Precautions..............................................................................................3 1.4 Technical Specifications of the Scanner.........................................................4 1.4.1 Connections.............................................................................................4 1.4.2 General Specifications.............................................................................5

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System Set-up .......................................................................................................7 2.1 Basic Set Up ...................................................................................................7 2.2 Programming Basic Settings...........................................................................8

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Planned Maintenance ..........................................................................................15 3.1 Handling and Care 100 Falco .......................................................................15 3.2 Handling and Care probes............................................................................15 3.2.1 Basic precautions probes ......................................................................15 3.2.2 Additional precautions for intraoperative probes. ..................................15 3.2.3 Additional precautions for the needle guide. .........................................15 3.2.4 Agents and procedures that may damage the probes...........................16 3.2.5 General probe cleaning .........................................................................16 3.2.6 Maintenance of the intraoperative probes .............................................16 3.2.7 Maintenance of probes other than intraoperative ..................................17 3.2.8 Others....................................................................................................17

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Corrective Maintenance .......................................................................................19 4.1 Unit disassembly...........................................................................................19 4.1.1 Unit ........................................................................................................19 4.1.2 Accessing the switched power supply ...................................................19 4.1.3 Accessing the main board .....................................................................20 4.1.4 Accessing the monitor board .................................................................20 4.2 Connector overview ......................................................................................21 4.2.1 Main board.............................................................................................21 4.2.2 switched power supply...........................................................................22 4.2.3 internal monitor......................................................................................22 4.2.4 Video and gain control board.................................................................23 4.2.5 Track ball and ON/OFF board ...............................................................23 4.3 Keyboard & ON/OFF circuit ..........................................................................24 4.3.1 Keyboard matrix ....................................................................................24 4.3.2 ON/OFF circuit.......................................................................................25 4.4 Parts list ........................................................................................................26

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Explanations ........................................................................................................27 5.1 Main board....................................................................................................28 5.1.1 Digital Control ........................................................................................28 5.1.2 Analog processing .................................................................................29

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Service information ............................................................................................. 30 6.1 Saving & restoring settings........................................................................... 30 6.2 Saving & restoring software ......................................................................... 30 6.3 Hidden test menu ......................................................................................... 31 6.4 Changing video format and mains voltage ................................................... 34 6.4.1 Video Format ........................................................................................ 34 6.4.2 Mains voltage........................................................................................ 34 6.5 External keyboard functions......................................................................... 35 6.6 Problem localizer.......................................................................................... 36 6.7 Battery operation.......................................................................................... 39

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Software .............................................................................................................. 40 7.1 Software versions......................................................................................... 40 7.2 Installation instructions................................................................................. 45

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System verification .............................................................................................. 46 8.1 Checking probes .......................................................................................... 46 8.1.1 Checking electronic probes................................................................... 46 8.1.2 Checking mechanical probes ................................................................ 47 8.2 Checking unit ............................................................................................... 48

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ESD..................................................................................................................... 49 9.1.1 What is ESD ......................................................................................... 49 9.1.2 Preventing ESD damage ...................................................................... 49 9.1.3 ESD save workshop.............................................................................. 50 9.1.4 ESD safe field service........................................................................... 51 9.1.5 More information about ESD precautions. ............................................ 51

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1 Introduction 1.1

About this manual

This service manual can be used to service the 100 Falco on board level. The manual explains the functioning of the boards by means of functional block diagrams while connections can be check at the connector overview. Preventive and corrective maintenance is also included. The circuit diagrams are only provided at the advanced service training 100 Falco, training level S12.

1.2

The 100 Falco

The 100 Falco is a high quality Linear Array and Curved Array scanner. The wide variety of probes and software programs makes it suitable for virtually all-diagnostic applications. • Linear Array technology A Linear Array probe is made up of, typically 80 or more, small rectangular crystal elements mounted side by side to form a single strip. By triggering the elements sequentially in groups, a rectangular ultrasound image is built up whose width approximates the length of the array. The ultrasound beam can be focused by using delay-lines to shape the wave front transmitted by the crystal groups. Furthermore, by changing the beam shape in sequential frames it is possible to work with multiple focal points. The advantage of the Linear Array is its wide near field, which can be of particular importance in Small Parts scanning. • Curved Array technology Curved Array technology is the same as Linear Array in every respect, except that the crystal elements are formed into a curve, rather than into a straight line, which gives a diverging ultrasound image. The advantages of a curved array are its wide far field, coupled to a small "footprint," or narrow near field, which is often of advantage in abdominal scanning.

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1.3

Warnings and Precautions

1.3.1 Warnings • A probe may only be connected to or disconnected from the scanner while the instrument is switched off. Ignoring this may cause severe damage to your scanner and/or probe. • To avoid a risk of explosion the equipment must not be operated in the presence of flammable anesthetics. • To avoid a risk of electric shock do not open the equipment. Refer servicing to qualified personnel only. • Be careful not to place the patient into contact with the ultrasound equipment or other devices. If the ultrasound equipment or other devices are defective, there is a risk of electrical shock. • For continued protection against fire hazard, replace fuses only with the same type and rating. • The use of non-Pie Medical components with this scanner may result in damage to Pie Medical components. • To prevent hazards, refer to your local requirements for adequate electrical installation in case of class 1 type BF equipment. • Do not subject the equipment to excessive shock, for example, when moving the equipment. If the equipment is repeatedly subjected to excessive shock, mechanical parts may be damaged. • Assembly operations, extensions, re-adjustments, modifications or repairs must be carried out by authorized persons. • The electrical installation of the relevant room must comply with the IEC requirements. • The product must be used in accordance with the instructions for use.

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1.3.2 Precautions • Cleaning the probe is done by first removing the ultrasound coupling gel with a soft tissue and then gently wipe the probe dry using a new tissue or dry cloth. • When more cleaning is required only a mild detergent or hand-soap may be used together with some water and a soft tissue cloth. • To avoid possible damage, the probe cable must not be coiled to a diameter of less than 9 cm (3.5 inch). • Although there is no danger to a patient with an implantable pulse generator (IPG), ultrasonic scanning equipment could cause mechanical damage to the IPG if used directly over the device's implant site. • Do not use the equipment in locations subject to intense electric or magnetic fields (near transformers, for example). If the equipment is used in such locations, the monitor will be adversely affected. • Do not use the equipment near devices generating high frequencies (such as medical telemeters and cordless telephones). If used near such devices, the equipment may malfunction or adversely affect such devices. • To guarantee proper unit operation do not operate the scanner in an environment with a temperature in excess of 35 °C. If the equipment is used in a small room, the room temperature may rise. Proper ventilation must be provided. • Avoid installation near a heater or in direct sunlight. • For correct image geometry, only monitors properly adjusted by the manufacturer may be used on the scanner. • Inspect the probe carefully after a drop. A dangerous situation may arise due to damaged insulation of the probe surface. • To prevent damage to mechanical probes due to excessive heat, a warning mechanism has been built into the system. • Use of the needle guide is only allowed when the probe is covered with a sterile hose or condom. • Handle needle guides with care. Do not use the needle guide if it is deformed in any way. • Needle guides are not shipped sterile, or disinfected.

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1.4 Technical Specifications of the Scanner 1.4.1 Connections 100/130V 200/240V

Power input: Connects instrument to operating power. The identification label at the rear of the instrument specifies the voltage setting of the instrument.

FUSES

100-240V : 2 x 3.15 AT The fuses are located in the mains entry at the back of the unit. The fuses should be replaced with fuses of the same type and rating:

Equipotentiality equalization

To connect the scanner to the potential busbar of the electrical installation.

Video OUT:

Video output terminal. 1V(p-p), 75 Ohm.

Video recorder IN: OUT:

Video input terminal, for display of recorded images via the scanner monitor. 1V(p-p), 75 Ohm. Video output terminal for video recording or printing purposes. 1V(p-p), 75 Ohm.

Footswitch

Connector for the freeze and M-mode selection footswitch.

RS-232

Terminal connector for factory test purposes, and computer interface.

Probe connections

One probe can be connected.

Diskette drive

Floppy disk drive for image and data storage.

External keyboard

An AT keyboard can be connected to this connector.

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1.4.2 General Specifications Scanning methods

Multifocus Linear array Multifocus Curved array

Display Modes

B, Dual B, M, B and M

Scanconverter

Full digital, 512x512x8

Post processing

10 Gamma correction curves

Patient ID

On-screen alphanumeric keypad or external keyboard

Caliper

Microprocessor controlled, multifunctional measurement system, able to measure Distance, Length, Area, Circumference, angle, Time, Volume and speed. Also controls the different calculation packages for Obstetrics, Gynecology, Urology, and Cardiology.

Display format

Composite Video out EIA/CCIR 1Vp-p, 75 Ohm

Mains

110V/220Volt, 50/60 Hz, 110 VA (max)

Battery Type:

12 Volt DC rechargeable Panasonic Rechargeable Sealed Lead-Acid battery LC-R127R2P (12V, 7.2 Ah / 20 HR) Constant Voltage Charge Cycle use : 14.5 – 14.9 V (25º C) (Initial current : less then 2.88A) Standby use : 13.6 – 13.8 V (25º C) NOTE: Replace battery with same type and specifications only.

Dimensions

W x D x H = 33 x 45 x 29 cm

Weight

11 kg without battery

Enclosure leakage and Earth leakage current

Within specifications for class 1type BF according to IEC 601-1. For ECG input type CF according to IEC 601-1.

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Environmental Operating conditions

Temperature 8-34 ºC Humidity up to 90% (20 ºC)

General storage conditions

Temperature 0-50 º C

Standards

IEC 601-1, Class1, Type BF, internally powered

Systems accuracies

Diameter, length, circumference and corresponding calculations (e.g. BPDdiameter) are better then 90%. Volume and weight are estimates.

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2

System Set-up

2.1

Basic Set Up

• Check the probe(s) (housing, cable and connector) as well as the scanner for damage. • Connect the probe(s) to the scanner. The scanner has two connectors at the rear of the system. • Press the connector of the probe, with the cable pointing down, into the connector of the scanner and push firmly. NOTE: A probe may only be connected to, or disconnected from the scanner while the instrument is switched off. Ignoring this may cause severe damage to the scanner and/or probe. • Before connecting the mains cable verify that the mains voltage matches the mains voltage indicated on the serial number sticker. • If a video printer is available, connect the video input of the printer to the video output of the scanner marked:

• If a footswitch is available connect it to the connector on the rear of the scanner marked: • If a VCR is available connect the video output of the VCR to the video input of the scanner marked:

• and the video output of the scanner marked:

to the video input of the VCR. NOTE: If several video devices are chained to one source, make sure they are all set to HiZ or High Impedance, except for the last device in the chain whose impedance must be 75 Ohm. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: • Use of the accessory in the PATIENT VICINITY. • Evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 601-1/IEC950 and / or IEC 601-1-1 harmonized national standard. DOC # 53B43SM03

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• To prevent hazards refer to your local requirements for adequate electrical installation. • Adjust intensity and contrast on the monitor until all gray tones on the bar are clearly distinguished from each other and from the background black. The image is best viewed in a darkened room. Monitor adjustments may have to be repeated when the surrounding light level changes.

2.2

Programming Basic Settings

Basic settings are settings that are stored in the non volatile memory of the scanner. This means that when the mains power is switched off the settings will remain in memory. After start up, the scanner is set to the basic settings that are programmed. Note: The described menu’s can vary due to software version differences. The following menu’s are applicable for software version C:4.0. Program settings The scanner is completely programmable to your liking. You can program the scanner for different users or applications. Before you start programming the scanner it is essential that you program the name of the user or the name of the application by adding this name to the user menu. Press SELECT and the Main menu will appear on the screen. Obstetrics Gynecology Urology Cardiology Specials Save recall image Text Body marks Goto User Applications Program Multi measurement Memory About the scanner

=> => => => => => => => => => => => => => =>

Select Program. The Program menu consists of a number of items that can be programmed according to your wishes. NOTE: Be aware that you have to store the programmed functions by selecting "Save settings" in the user menu. Before you store the programmed functions you must check which user (by checking the user name) is activated. The (active) user name will be marked with a √.

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System settings Select System settings. System settings Caliper settings Text settings Grey maps Goto Macro User Tables Compose fetal age Help Installation Extern video

=> => => => => => => => =>

The System settings menu will be displayed on the screen: Time & date Time format Date format Watchdog Scale format Ball sensitivity Colour

=> => => => => =>

Time & date Select Time & date in this menu. A new menu appears: Time (HH:MM:SS) Date (YYYY-MM-DD)

14:52:03 1998-10-15

With the numeric keys of the keypad a new Time can now be entered. Use the trackball to move the cursor to Date and use the numeric keys of the keypad to enter the date. When the new time and/or date is entered, the SELECT key must be pressed. The updated time and date are now stored in memory. The time and date are displayed in the left top corner of the screen.

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Time format With Time format the display of time can be altered. Selecting Time format will generate the following menu: HH:MM:SS HH:MM AM/PM

..:..

HH:MM:SS HH:MM AM/PM

(Time is displayed in 24 hour format) (Time is displayed in 12 hour format)

Activate the Time format of your choice. Date format With Date format the display of date can be altered. Activate the Date format of your choice. Selecting Date format will give you the following menu: MM/DD/YY YY-MM-DD DD.MM.YY DD-MM-YY DD/MM/YY ../../.. Activate Date format of your choice. Watchdog The scanner can be programmed to switch off the mechanical probe and the keypad illumination automatically, if the unit has not been used for a certain period of time. This feature, called Watchdog, can be activated as follows: Return to the System settings menu, and select Watchdog. The following menu will appear on the screen: Off Short Normal Long Off: Short: Normal: Long:

The scanner will not go on standby. The scanner will go on standby after ± 1 min. The scanner will go on standby after ± 10 min. The scanner will go on standby after ± 1/2 hour.

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Scale format The Scale format gives you an indication of the depth and breadth of the image. Return to the System settings menu, and select Scale format. A menu with two scale formats appears on the screen. The first format is without the actual cm numbers next to the scale, the second one shows the actual numbers. Move the cursor to the scale format of your choice and press SELECT again. The chosen scale format will now be installed. Ball sensitivity The sensitivity of the cursor movement in relation to the trackball can be programmed. Return to the System settings menu and activate the Ball sensitivity. The following menu appears on the screen: High sensitivity Medium sensitivity Low sensitivity You can now choose between high, medium and low sensitivity. In high sensitivity the cursor or caliper will jump immediately to another position when the trackball is moved lightly. In low sensitivity the cursor or caliper will move only when the trackball is rolled firmly. Colour Return to the System settings menu and select Colour. The colour of the caliper cross and the text displayed in the image can be selected to be White, Grey or Dark gray. White Grey Dark gray The criterion is the average brightness of structures to be visualized. If images in which measurements have to take place are often light, a darker cursor may be selected to make it more visible.

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Installation Return to the Program menu and select Installation. The Installation menu will be displayed on the screen: Settings Language PC Keyboard Main menu Measurement unit Weight unit

=> => => => => =>

Settings The settings window will be displayed as follows: Install default settings => Install settings from disk => Current settings to disk => Install scanner software => Install default settings Select Install default settings. A menu appears and you can choose between YES or NO. Selecting YES: The original settings installed by the manufacturer will now be activated (All the settings programmed will be erased). Selecting NO: The menu structure will disappear from the screen. You can continue. The stored settings will remain stored in the scanner. Settings to/from disk The settings to/from disk menu can be used to save and restore user settings to and from floppy disk. When selecting follow on screen instructions. Install scanner software In 100 Falco the software can be loaded from floppy disk and a back up of the installed software version can be made. Select Install software and follow on screen instructions.

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Language Return to the Installation menu and select Language. From the menu that appears you now can choose Dutch, English, French, German, Spanish or Italian. PC Keyboard Return to the Installation menu and select PC keyboard. From the menu that appears you can choose the type of external keyboard that can be connected to the scanner (English, German and French). Main menu Return to the Installation menu and select Main menu. A new menu will be displayed: Obstetrics Gynecology Urology Cardiology Veterinary Specials Animal Science From this menu the different applications can be selected (√ √) or deselected by pressing SELECT. Selected applications will be displayed in the Main menu. Measurement unit Measurement unit. A new menu will be displayed: cm inch Now you can choose by selecting the corresponding item if you want to display the scale-bar on the screen in centimeters (cm) or in inches (inch).

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Weight unit Weight unit. A new menu will be displayed: kg lbs Now you can choose by selecting the corresponding item if you want to display the weight on the screen in kilograms (kg) or in pounds (lbs). The items of the program menu have now been described and perhaps you have programmed items different from those originally programmed by the manufacturer. We remind you again that in order for the scanner memorize these changes they should be saved under a user.

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3 Planned Maintenance 3.1

Handling and Care 100 Falco

Although the scanner is produced with the utmost care and only the highest quality components are used, maintenance will be necessary from time to time to ensure trouble-free operation. • Remove loose dust from the exterior with a soft cloth or a dry brush. A solution of water with a mild detergent may be used. Avoid aggressive cleaners. • Check the ventilation fans of the unit for proper operation. • Clean the track ball • remove the track ball ring by turning counter clock wise • remove the ball, adhesive tape might help to remove the ball • clean the ball and O rings that touches the ball with alcohol.

3.2

Handling and Care probes

3.2.1 Basic precautions probes Always follow these basic precautions: • Inspect the probe daily for cracks and other damage. • DO NOT use a probe that has been cracked or damaged. • DO NOT use a probe that has been dropped or struck against another object until it is inspected by a service engineer. • Avoid pinching or kinking the probe cable. If the probe housing becomes cracked or broken or if there are cuts or openings in the probe cable the electric safety of the probe could be compromised. • Disconnect the probe from the scanner before cleaning and disinfection. Make sure to switch the system off before disconnecting or connecting the probe. 3.2.2 Additional precautions for intraoperative probes. Always follow these additional precautions for intraoperative probes: • Clean and disinfect the probe prior to use and between each exam. • Use a protective sterile probe cover or hose to cover the probe during patient exams. • To avoid patient-to-patient contamination always dispose of probe cover and hose immediately after each examination. 3.2.3 Additional precautions for the needle guide. Always refer to the instructions delivered with the individual needle guide.

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3.2.4 Agents and procedures that may damage the probes. Some agents and procedures damage probes. Use of any of the following procedures or products WILL VOID your probe warranty. Agents that contain the following chemicals are known to damage the probe: • Acetone • Methanol • Denatured ethyl alcohol • Mineral oil • Iodine • Any lotions or gels containing perfume Check with the ultrasound gel manufacturer regarding gel contents. If you have additional questions, please contact your representative. The following procedures are known to damage probes: • Autoclaving • Soaking the probe in chlorine bleach 3.2.5 General probe cleaning Cleaning the probe is done by first removing the ultrasound coupling gel with a soft tissue and then gently wipe the probe dry using a new tissue or dry cloth. When more cleaning is required only a mild detergent or hand-soap may be used together with some water and a soft tissue cloth. 3.2.6 Maintenance of the intraoperative probes • After each exam, regard the probe hose and any other wastes as potentially infectious and dispose immediately. • Wipe the probe clean with a towel. • Scrub the probe with water and a mild detergent. Use a soft cloth or towel. Never use an abrasive sponge. • Disinfect the probe using Cidex‘ Activated Dialdehyde Solution according to the manufacturer's directions. After it has been cleaned and disinfected, the probes can be stored, either in the probe holder on the scanner, or in its original case. NOTE: Always follow these basic precautions for cleaning and high level disinfecting: DO NOT soak the probe in alcohol. Alcohol is nearly inactive against certain organisms. DO NOT rub the probe with an abrasive sponge when washing with soap and water. Use a soft cloth or towel.

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3.2.7 Maintenance of probes other than intraoperative • Clean the probe after each examination by wiping off the coupling gel residues and other impurities. • Wash the probe with a mild detergent and water every day. • Store the probe in the probe holder on the scanner or place the probe in its original storage case. 3.2.8 Others For a proper use of the probes the following additional items are necessary: • Protective probe covers (for invasive probes). • High level disinfection solution (Use recommended brand only). • Ultrasound coupling gel. • Needle guide. • Probe holder and tray. This section “Others” briefly describes these supporting materials and for some of them vendors are listed. Also vendors not listed may be able to provide these items. The manufacturer does not endorse any product on any basis. Rather, on empirical evidence, it is confirmed that these items as being acceptable to maintaining the system and service warranty status in full. Protective probe covers You can use the intraoperative probe with gamma sterilized probe hoses. These probe hoses are open on 2 sides, measurements are: • Length 200 cm • Width 10 cm • Material thickness 0.05 mm These hoses are not intended for reuse. Also discard the hoses if the expiration date of the sterilization, as indicated on the package, is exceeded. Severe allergic reactions, although infrequent, have been reported with medical devices containing latex (natural rubber). Inquire for known latex sensitivity before using latex probe covers and be prepared to treat allergic reactions promptly if they occur. Ref. FDA Medical Alert MDA 91-1, March 29, 1991. Products for high level disinfection Cidex‘ Activated Dialdehyde Solution is available from: Surgikos, Inc. P.O. Box 130 Arlington, Texas 76010 800-433-5009 (Within Texas: (817) 465-3141) Technical information is available from the manufacturer. Call Johnson & Johnson Medical Inc. Customer Relations at 800-423-5850.

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Ultrasound coupling gel Use an ultrasound coupling gel to prepare the probe for an exam. Certain ultrasound gels may be toxic to human reproductive cells. It is recommended that you check with the product's manufacturer to determine appropriate use. Refer to the "Agents and procedures that may damage probes" earlier in this section for additional information about coupling gels. Needle guide • Clean the needle guide before, after and between each examination until no visible tissue residue, fluid or other material remains on the needle guide. Scrub the needle guide with water and a mild detergent. Use pipe cleaners to clean the inner lumen of the needle guide. • Sterilize the needle guide prior to the first use and between all subsequent examinations. There are two ways to sterilize the needle guide: • Steam autoclaving. • Soaking the needle guide in Cidex‘ Activated Dialdehyde Solution according to the manufacturer's directions. • After sterilizing the needle guide, rinse it in sterile water. • Store the needle guide in a plastic bag in the original probe storage container. Probe holder and tray • Every day loose dust or coupling gel residues should be removed with a soft cloth or a brush. A solution of water with a mild detergent is recommended. Abrasive cleansing solutions should be avoided. The tray can be removed for cleaning. • Check after cleaning the probe holders and probe tray for visual damage.

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4 Corrective Maintenance 4.1

Unit disassembly

4.1.1 Unit 1. Disconnect main cable. 2. Remove probe cover and probe. 3. Place Scanner 100, on foam, with the monitor screen pointed downwards. 4. Remove the battery compartment cover and battery. 5. Remove the 6 screws indicated by # 1 and shift the back part housing upwards. 6. Remove the carrying bar.

1

1

1

4.1.2 Accessing the switched power supply 1. 2. 3. 4.

See 4.1.1 Unit. Remove the screws indicated by # 2. Loosen, do not remove, the screws indicated by # 3. Open the cover.

2

2

2 Switched Power Supply

2

3

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4.1.3 Accessing the main board 1. See 4.1.1 Unit. 2. Disconnect the connectors from the main board assembly. 3. Loosen, do not remove, the four screws marked by # 4.

4

5

4

4. Shift the main board assembly carefully backwards. 5. Disconnect the keyboard cable and trackball cable from main board assembly and then remove the main board assembly. 6. To access the main board, remove the cover # 5. 4.1.4 Accessing the monitor board 1. See 4.1.2 Accessing the switched power supply. 2. Remove the screws marked with # 6. 3. Disconnect the connector to the monitor board and remove the monitor board

6

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4.2

Connector overview

4.2.1 Main board

P22 is not used in 100 Falco Dipswitch setting for 100 Falco: bit 1 = ON bit 2...8 = OFF

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4.2.2 switched power supply switched power supply version: Advantec ret ret GND Vaccu Vaccu

ret HV switch ret HV sel POWon Batlow ret ret ret +5V +5V +13V +13V +13V -12V -12V -70V ret +70V ret -180V

220 V position 110 V position

ret: HV switch (HVEN):

GND “0”= High Voltage disabled “1”= High Voltage enabled HV Sel: not used, always “0” POWon (ON/OFF): “0”= switched power supply enabled “1”= switched power supply disabled Batlow: “1”= battery full “0”= battery empty (battery low icon is displayed) 4.2.3 internal monitor

GND -Brightness Brightness Cont . max Cont. wp 13 V Video in Cont. min GND

Contrast

H wi dt h

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H sh ift

Brightness

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4.2.4 Video and gain control board

4.2.5 Track ball and ON/OFF board

Connector P1 is connected to the main board P4003. Connector P2 is connected to keyboard connector P4. Connector P3 is connected to keyboard connector P3.

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4.3

Keyboard & ON/OFF circuit

4.3.1 Keyboard matrix

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4.3.2 ON/OFF circuit The ON/OFF board incorporates the take over relay for the ON key on the keyboard.

The switched power supply will start up when the ON/OFF signal is connected to GND. When pressing the ON key on the keyboard, ON/OFF is connected to GND and the switched power supply starts up. As a result the +5 V will be available and relay R2 becomes active. The take over contact closes and the ON/OFF signal is connected to GND. To switch off the unit the OFF key on the keyboard has to be pressed. The transistor activates relay R1 and the contact will open. This will disable relay R1 and the unit will switch off.

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4.4

Parts list

For up to date parts list refer to Pie Medical Service magazine Description

Art #

Mainboard assy in metal shielding Video monitor unit, CCIR/EIA Power supply Trackball assembly Keyboard Falco Battery 3.5" Floppy Disk Drive Housing, plastic part only Handle Battery compartment cover Re-charger Fan Gain potentiometer 10k, near/far/total/contrast/brightness

710063 710064 700147 310440 310487 401515 308508 307589 307568 307561 401534 307730 205119

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5 Explanations The 100 Falco is a 30 channel system and can operate with Linear Array and Curved Array probes. The image is displayed on a 9” internal monitor. The floppy disk, keyboard and track ball are used as user interface. The switched power supply provides the supply voltage for the main board, multi connector board and internal monitor and it generates the high voltage, used for acoustic power, as well. Almost all functions are located on the main board. All analog processing of ultrasound data is done in the “analog processing circuit”. All transmit and receive settings are controlled by the Digital receiver.

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5.1

Main board

The functions of the main board are divided over 2 functional blocks: • Digital control • Analog processing 5.1.1 Digital Control The digital control includes the CPU function. The CPU circuit is built around a 68020 processor. The software for this processor is loaded in FLASH PROMS and the software can be downloaded from floppy disk. User settings are also stored in FLASH PROMS. All user settings can be saved and retrieved to and from floppy disk. See chapter 6, Service information page 30. A Real Time Clock is used to display the time and date. The digital receiver controls all settings for the analog processing. All transmit and receive settings are generated by this circuit as well as the control signals to position the crystal in mechanical probes. Digital samples are taken from the received ultrasound information Zout. The orientation of the samples is from top to bottom while the video lines are from left to right. The converter changes the up/down orientation of the ultrasound information into left/right orientation for video.

The interpolated ultrasound data and overlay (text and menus) are converted into the analog video signal in the video stage.

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5.1.2 Analog processing The analog processing takes care of transmitting and receiving the ultrasound waves. The unit is a 30 channel system and therefor there are 30 pulsers and 30 pre-amps. The EP signal (emission pulse) triggers the pulser that generates the high voltage pulse which causes the crystal to start oscillating. The crystals starts transmitting. After transmitting the crystals are receiving returned ultrasound information. This amplitude modulated information is amplified by the PRETGC amplifier. The PreAmp is a voltage controlled amplifier that amplifies the returned signal in relation to the depth. The larger the depth the more amplification is needed to display the same intensity for the same tissue. These losses of intensity are caused by absorption and scattering.

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6 Service information 6.1

Saving & restoring settings

In 100 Falco all system settings can be loaded from floppy disk and a back up of the installed settings can be made. Only use DOS formatted HD 1.44 MB floppy disks. Press: Now select: Now select: Now select:

SELECT Program Installation Settings

The installation window will be displayed as follows: Install default settings Install settings from disk Current settings to disk Install scanner software

=> => => =>

Now select: Settings to/from disk. Follow the on screen instructions.

6.2

Saving & restoring software

In 100 Falco the software can be loaded from floppy disk and a back up of the installed software version can be made. Only use DOS formatted HD 1.44 MB floppy disks. Press: Now select: Now select: Now select:

SELECT Program Installation Settings

The installation window will be displayed as follows: Install default settings Install settings from disk Current settings to disk Install scanner software

=> => => =>

Now select: Install software. Follow the on screen instructions. When installing new software it is advisable to make a back up of the installed software version first (4 DOS formatted HD 1.44 MD floppy disks needed).

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6.3

Hidden test menu

The test menu is a service purpose menu and may be activated by authorized personnel only. To activate the test menu, connect an external keyboard and type: secret The following menu is displayed: Show console Bourne shell Debuggers Windows demo Performance Test Pattern Probe info Biopsy angle Lateral correction Show diagnostics Codes Installation

=> => => => => => => => => => => =>

Show console This menu will display error messages, recognized by the software, at the active moment. Bourne shell The only instruction that may be entered in this menu is; pdiag –c [return] This function will erase the data displayed in the Show diagnostics menu. Debuggers Used at factory only.

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Windows demo Selecting this menu will display the following menu: Move Beethoven See Zebra See Penguins Lifetest

=> => => =>

Lifetest In lifetest mode the scanner activates all possible image modes. Performance A performance meter is displayed and indicates the activity of MPU and interrupts. Test Pattern Used at factory only. Probe info This menu displays information about the active probe, such as: image mode probe type probe code number of echo lines line time number of Mmode and Bmode lines Biopsy angle Used at factory only. Changing these settings may cause wrong diagnosis. Lateral correction Used at factory only. Changing these settings may cause wrong diagnosis.

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Show diagnostics This menu shows an error log file. The log file can be erased in the Bourne shell. Codes Used at factory only. Installation Selecting this menu will display the following menu: Video setting See 6.4.1 Video Format, page 34.

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6.4

Changing video format and mains voltage

6.4.1 Video Format The video setting EIA or CCIR can be set through the software menus. To activate the test menu, connect an external keyboard and type: secret Now select INSTALLATION and then VIDEO STANDARD. Select the requested video standard (EIA is 525 video lines, CCIR is 625 video lines). After pressing SELECT the system will restart. The internal monitor will adapt automatically to the selected video standard and does not need to be re-adjusted. 6.4.2 Mains voltage NOTE Always turn system power off and remove the power cord from the power source before working on the switched power supply. Remove the back part housing as described in section 4.1.1Unit, page 19 and set the mains voltages selector to the required position.

NOTE After changing the mains input voltage or the video format change the ID label as well

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6.5

External keyboard functions

KEY ALT SHIFT CTRL

F1 B BMline BPD TXT1

F2 B+B

F4 B+M

F5 FOCUS

F6 ZONE

FL TXT2

F3 M Mspeed CRL TXT3

AD TXT4

AC TXT5

HC TXT6

KEY ALT SHIFT CTRL

F7 DEPTDMIN US1 TXT7

F8 DEPTH+ DMAX US2 CURSOR

F9 FREQ BIOPSY EDD COMP.

F10 M1 M3 LMP BODYM

F11 M2 M4

F12 SAVE RECALL NEW PATIENT

SPECIAL KEYS KEY ESCAPE PAUSE PRINTSCR HOME END PAGE UP PAGE DO CURSOR KEYS NUM LOCK

FUNCTION ESCAPE FREEZE PRINT QUIT MENU AGAIN ESCAPE START CURSOR KEYS BALL EMULATION ON/OFF

KEY NUM LOCK ON

FUNCTION NORMAL

NUMLOCK OFF

BALL EMULATION

1, 7 3, 9 0 8 2 4 6

START ESCAPE SET BALL UP BALL DOWN BALL LEFT BALL RIGHT

CTRL _ ALT _ DEL = NEW PATIENT

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6.6

Problem localizer

Problem description No proper start up

Possible cause keyboard unit switched power supply MPU circuit, on main board

Action #1 Connect signal ON/OFF, main board connector P4014 pin 3 (yellow wire) to GND (connect by means of a pair of tweezers to the metal shielding. Now there are 3 possibilities: 1. nothing happens: switched power supply defective or problem in MPU circuit. 2. scanner starts up and remains on, even when disconnected from GND: problem in keyboard. 3. scanner starts up and shuts down when disconnecting the ON/OFF signal from GND: problem in ON/OFF. Problem description No image on monitor

Possible cause no start up Brightness/Contrast settings internal monitor video stage, on main board

Action #1 Check brightness and contrast Action #2 When probes are active (LED is lit) and when pressing a key on the keyboard a beep can be heard, the MPU is running. If not: see No start up Action #3 Connect external video monitor or video printer: Image on external monitor/printer: Internal monitor defective Action #4 No image on external monitor/printer: main board defective

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Problem description Probe not recognized by scanner

Possible cause Software Probe Main board

Action #1 Check software version of scanner (about scanner menu) and check minimum software version for probe model in the service magazine or Chapter 7 Software Software versions, page 40 Action #2 Check probe connector for broken pins and check probe on other scanner (with correct software version installed. Action #3 If software is correct and probe is OK, problem on main board. Problem description No ultrasound information

Possible cause Gain settings Probe High voltage not present RF circuit, on main board

Action #1 Check gain potentiometer settings and gain settings in Probe/TGC menu. Action #2 Try other probe, or probe on other system. Action #3 Measure the High Voltage, generated on the switched power supply. (on main board connector P22 pin 7 (-70V) and P22 pin 8 (+70V) or on switched power supply). • High Voltage not present: switched power supply defective or control signal HVEN always “0”. • High Voltage present: problem on main board

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Problem description Poor ultrasound information

Possible cause Image and Gain settings Probe High voltage not present RF circuit, on main board

Action #1 Check gain potentiometer settings and gain settings in Probe/TGC menu. Check image settings such as focal points and Processing curve. Action #2 Try other probe, or probe on other system. Action #3 Measure the High Voltage, generated on the switched power supply. (on main board connector P22 pin 7 (-70V) and P22 pin 8 (+70V) or on switched power supply). • High Voltage not present: switched power supply defective or control signal HVEN always “0”. • High Voltage present: problem on main board Problem description Please insert disk message

Possible cause Floppy disk Disk drive Floppy controller

Action #1 Check floppy disk, only formatted HD disk can be used. Note that floppy disks may get corrupted when ejecting as the green LED of the floppy disk drive is still lit Action #2 Check floppy disk drive and cable to disk drive. Action #3 Problem on main board

Problem description High voltage malfunction message

Possible cause probe Main board Switched power supply

Action #1 If possible check unit with other probe or probe on other unit to detect which part is defective. Action #2 Measure the high voltage generated on the switched power supply. If present: main board defective. If not present: switched power supply defective.

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6.7 Battery operation The 100 Falco can be operated by using a battery. Below you will find frequently asked questions. Is the battery charged when delivered? Yes, but needs to be recharged before use. What is the maximum operation time when using the battery? One hour of constant scanning Is the battery charged when installed in the unit? Yes, as long as the mains cable is connected. What is the maximum charge time until the battery is completely full when the battery is installed in the unit? The charge time for batteries that are being charged when the “battery low” icon is displayed is 5 hours. For batteries that are completely empty (used until the scanner switches off when running on the battery) the charge time is 24 hours. What is the maximum charge time until the battery is completely full when using external charger, Model # 41534? Same as when charged in the unit. The advantage of the external charger and extra battery is off course that one battery can be charged while using the other. Is the battery discharged when the mains cable is not connected while stored? Yes. Depending on the switched power supply type the battery is discharged after 2 weeks. When storing the unit is it recommended to connect the mains cable or disconnect the battery? This depends on the storage period. For a short period (week) it is recommended to store with the mains connected. In this way the battery is recharged. When storing for months it is recommended to disconnect the battery. Storing with the mains connected does not influence the battery nor the switched power supply, it will only raise your electricity bill.

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7 Software 7.1 •

Software versions

Software version C:4.0

Available probes: (* marked are preferred) Article # 401512 401513 401518 401519 401520 401525 401586 401587 401612 * 401663 401664 * 401665 * 401667 * 401669 * 401670 * 401671 * 401785 401788 * 402198 * 410054 *

Description Needle guide type Curved Array R40 DF 3.5/5.0 MHz 80el 16ch Soft lens I Curved Array R17 5.0/7.5 MHz 80el 16ch Hard lens M Linear Array 5.0/7.5 MHz 64el 12ch 67mm Soft lens VET Linear Array 5.0/7.5 MHz 64el 12ch 67mm Soft lens B Linear Array 3.5/5.0 MHz 64el 12ch 120mm Soft lens A Linear Array 7.5 MHz 64el 12ch 40mm Hard lens K Curved Array R17 5.0/7.5 MHz 80el 16ch Soft lens M Curved Array R40 DF 3.5/5.0 MHz 80el 16ch Soft lens I Curved Array R40 HD 3.5 MHz 112el 30ch Soft lens I Linear Array 6.0/8.0 MHz 80el 30ch 60mm Soft lens L Curved Array R75 3.5/5.0 MHz 128el 30ch Soft lens A Curved Array R40 DF 3.5/5.0 MHz 80el 30ch Soft lens I Curved Array R17 5.0/7.5 MHz 80el 30ch Soft lens M Linear Array 3.5/5.0 MHz 80el 24ch 120mm Soft lens A Linear Array 6.0/8.0 MHz 80el 30ch 60mm Soft lens VET Linear Array 7.5 MHz 80el 30ch 40mm Soft lens N Curved Array R40 DF 3.5/5.0 MHz 80el 30ch Soft lens I Curved Array R10EC 5.0/7.5 MHz 128el 30ch Soft lens O Linear Array 8.0 MHz 128el 30ch 40mm Soft lens R Linear Array 6.0/8.0 MHz 80el 30ch 60mm Soft lens L

Available languages 1. English 2. Dutch 3. German 4. French 5. Italian 6. Spanish

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Available applications 1. Obstetrics 2. Gynecology 3. Urology 4. Cardiology 5. Veterinary 6. Specials 7. Animal science

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Available calculation packages: 1. Obstetrics Fetal age tables User programmable tables 2 per user (total of 10) EDD/LMP Calculation Manual Input LMP Ratio FW Calculated from BPD and AC measurements and Lookup table form Sheppard. Biophysical observations Observed fetal anatomy Observed maternal anatomy Report (5 pages) Available medical fetal age tables: AC

CRL

FL

OFD

Campbell Hadlock Hansmann Nicolaides Staudach Chitty Hansmann Robinson Staudach Rempen Hansmann Jeanty Nicolaides O'Brien Staudach Chitty Hansmann Nicolaides

C:002 C:001 C:002 C:000 C:002 C:000 C:004 C:003 C:004 C:000 (EV) C:003 C:001 C:000 C:001 C:003 C:000 C:000 C:000

AD

Eriksen Hansmann Staudach BPD Campbell Hansmann Kurtz Nicolaides Staudach Rempen Hadlock HC Campbell Hadlock Hansmann Nicolaides Staudach GSD Hellman Rempen MAD Rempen

C:002 C:002 C:002 C:002 C:003 C:001 C:000 C:003 C:000 (EV) C:000 C:003 C:001 C:001 C:000 C:001 C:001 C:000 (EV) C:000 (EV)

2. Gynecology: Uterus: Right Ovary: Left Ovary: Endometrium Report (2 pages)

Length, AP Diameter, Coronal Width Length, AP Diameter, Width Length, AP Diameter, Width

3. Urology: Kidney: Bladder: Prostate: DOC # 53B43SM03

Length, Height, Report Transverse, Sagittal, Oblique Coefficient, Report Transverse, Sagittal, Oblique Report 41

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4. Cardiology: Left ventricle calculations B-MODE DODGE SINGLE PLANE Left ventricle calculations B-MODE DODGE BIPLANE Left ventricle calculations B-MODE BULLET Left ventricle calculations M-MODE Left ATRIUM/AORTA calculations MITRAL VALVE calculations PULMONARY VALVE calculations Each with special report page 4. Veterinary Cardiology Left ventricle calculations B-MODE DODGE SINGLE PLANE Left ventricle calculations B-MODE DODGE BIPLANE Left ventricle calculations B-MODE BULLET Left ventricle calculations M-MODE Left ATRIUM/AORTA calculations MITRAL VALVE calculations PULMONARY VALVE calculations Each with special report page in which a selection for Cat, Horse and Dog can be made. In addition the weight of the dog can be programmed to obtain corresponding normal ranges. The Veterinary Cardiology selection is automatically made if the systems main menu contains either Veterinary or Animal Science. 5. Veterinary: Sheep Swine Bovine

Equine

Llama

CRL Heart LAX Stomach LAX CRL Trunk Diam. Brain Diam. CRL CRL Uterine Diam. Eyeball Diam. Rump Diam. Skull Diam. GSD BPD

Bogaard Fraunholz Fraunholz White White Kähn Kähn Hughes White Kähn Kähn Kähn Pipers Haibel

C:000 C:000 C:000 C:000 C:000 C:000 C:000 C:000 C:000 C:000 C:000 C:000 C:000 C:000

Report (2 pages)

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6. Specials: Graf: Thyroid: Volume:

Hip-Joint classification Volume measurement General volume measurement using 3 distances, D1, D2 and D3. Where V = π/6 x D1 x D2 x D3

7. Animal science: A special calculation program for Back-fat scanning and the determination of the percentage intermuscular fat for: Beef Hide thickness Fat thickness Loin thickness Loin area Quip Index Weight Sheep Fat thickness Loin thickness Loin area Weight Swine Fat thickness Loin thickness Loin area Weight Automatic Loin area calculation Report (3 pages) Known restrictions in this release • •

User interface language Russian is not yet supported. Images saved to floppy with Scanner 100/240/250+ cannot be loaded on 100 Falco/240 Parus/260 Corvus. Images saved to floppy with 100 Falco/240 Parus/260 Corvus cannot be loaded on Scanner 100/240/250+. System settings saved to floppy with Scanner 100/240/250+ cannot be loaded on 100 Falco/240 Parus/260 Corvus. System settings saved to floppy with 100 Falco/240 Parus/260 Corvus cannot be loaded on Scanner 100/240/250+. • Several .BMP viewers available under Microsoft Windows and Unix are not suitable for viewing images saved by SD 240E and SD240, due to a problem with aspect ratio. These include a.o. Microsoft Paint, Paintshop Pro, ACDSee, Graphic Work Shop, Xv (Unix), The Gimp (Unix). However they can be viewed correctly with “Imaging (Wang or Kodak)”, available in most releases of Microsoft Windows

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•

Software version C:4.1

Improvements: New probe: New functionality: •

402116 Curved Array R40 DF 3.5/5.0 MHz HiD 128 el 30ch, biopsy attachment S Num Lock on external keyboard default OFF

Software version C:4.2

Improvements: New probe: New functionality:

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410638 Curved Array R40 DF 3.5/5.0 MHz HiD 128 el 30ch Biophysical profile AFI measurement Twins measurement

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7.2

Installation instructions

• File extraction When the software file is received through e-mail or downloaded from the Pie Medical Support web page, the file C_N_N_N.exe should be extracted to obtain the software diskettes (where is N_N_N is the version). Four (4) PC Formatted diskettes (3.5 “, 1.44 Mb) are required to extract. Double click the file C_N_N_N.exe and allow the program to write the four diskettes. Clearly label the diskettes “100 Falco/240 Parus/260 Corvus release C:N.N#N” and number 1of 4 to 4 of 4. Diskette 4 of 4 is the “Language” diskette. •

Unit update

1. Start the software installation process by selecting menu: Program / Installation / Settings / Install software from disk 2. The system will prompt to make a backup of the installed software (3 diskettes required). If no other software diskettes are available this option is recommended. To save time the option may be skipped. 3. The system will prompt to erase the installed software version. Select YES. 4. The scanner will prompt to insert the software diskettes. Start with 1of 4, then 2 of 4 and 3 of 4. 5. When ready switch of the unit. Wait 10 seconds and switch on again. 6. The scanner will prompt for the “Language” diskette (4 of 4). Inserting will finalize the installation procedure.

Alternatively the scanner software installation process can be initiated in following way, even after a failed previous install: 1. Connect a standard two pedal footswitch. 2. Push both footswitch pedals simultaneously while switching on the scanner, to initiate the software loading process. 3. Proceed with step 2 above. • Note The diskettes labeled “100 Falco/240 Parus/260 Corvus release C:N.N#N” can be used to upgrade 100 Falco, 240 Parus and 260 Corvus. Diskettes obtained through the unit back-up facility can only be used to update the same type of unit. E.g. Diskettes with software retrieved through the back-up procedure in 100 Falco can not be used to up-grade a 240 Parus or 260 Corvus.

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8 System verification It might be obvious that judging image quality needs a lot of experience. When checking image quality aspects, it is therefor recommended to compare units by using an ultrasound equivalent tissue phantom. When scanning the ultrasound phantom watch for sufficient penetration, focal zones and noise level. When comparing two units, be sure that the Grey maps (press START, select Applications and then Grey maps) are set to the same setting. Grey map 4 and 5 are programmable. The checks mentioned below are functional checks and do not include image quality aspects.

8.1

Checking probes

Before connecting probes to the scanner check for visual damages. Dangerous situations might occur due to cracks or other damage due to service abuse. 8.1.1 Checking electronic probes Electronic probes need to be checked on element dropouts and channel dropouts. This can be done, by sliding a small needle or screwdriver along the crystal. When doing this, a white reflection will be visible in the ultrasound image and the position of the reflection corresponds with the position of the needle.

When at a certain position no reflection is displayed, it indicates that this element is not active.

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The smallest reflection is obtained when selecting F1 only and switch of DNF.

The element/channel dropouts can also be seen when scanning an ultrasound equivalent tissue phantom. 8.1.2 Checking mechanical probes When connecting a mechanical probe check whether the motor runs smoothly or not. Check at all the image angles. The lateral correction need to checked as well. • Switch off DNF. • Make a scan of the ultrasound equivalent tissue phantom. • Check at the center of the field of interest whether the image is shaking left and right for both low and high frame rate. Check the functionality of the focal zones by selecting different focal points (if possible).

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8.2 • • • • • • • • • • • • • •

Checking unit

Connect a good working probe and switch on the unit. Check if the scanner starts up correctly and that the probe is recognized correctly. Check the functionality of the gain and bright/contrast potentiometers. Set the gain potentiometers in mid position. Adjust the brightness and contrast potentiometers in such way that the 8 steps in the grayscale are visualized. Check the video output by means of an external monitor or video printer. Check the video input by means of a VCR or video generator. Check the footswitch and PC keyboard functionality. Activate all functions accessible directly from the keyboard. Make a scan of an ultrasound equivalent tissue phantom. Check if there is ultrasound information visible in all possible depths. Select maximum depth. Check for sufficient penetration and noise level. Activate, if possible, all possible focal zones and watch the image change accordingly.

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9 ESD 9.1.1 What is ESD Electro Static Discharge (ESD) is the transmission of electro static charges between two bodies with a potential difference. This transmission can be achieved by direct contact or by an inducted electro static field. Electro static discharges are not always noticed by men, because ESD is: • sensed at 3.500 Volt • audible at 4.500 Volt • visible at 5.000 Volt Components and integrated circuits are more sensitive as men and might be damaged by lower voltage discharges. component type V-MOS mosFET EPROM JFET OP-AMP C-MOS Schottky Diodes Bipolar Transistors ECL SCR Schottkey TTL

ESD sensitivity in Volts 30-1800 100-200 100 140-7000 190-2500 250-3000 300-2000 380-7000 500-1500 680-1000 1000-2500

9.1.2 Preventing ESD damage • Use electro static sensitive parts only in an ESD safe workshop. • Use ESD safe packing material. • Remove all static chargeable materials (plastics) from the workshop. • Wear ESD safe clothing. • Always check wrist strap and other ESD equipment before use. • Be grounded. • BE AWARE.

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9.1.3 ESD save workshop To be sure that the is no potential difference between body, boards and work surface, the work surface should be made of electrostatic dissipative rubber. The work surface should be connected to a central ground point. The engineer, handling the boards should also be connected to the central ground point, either through wrist strap or heal strap (and conductive floor).

Electrostatic dissipative rubber mat

Pie Medical

Scanner 100

To central GND point

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9.1.4 ESD safe field service To enable ESD field safe service an ESD field service kit has to be used when handling boards. This ESD field service kit should be connected to a central ground point and the service engineer should be connected to the ESD field service kit through a wrist strap. Handle boards only on this ESD field service kit and pack in ESD safe packing material.

To central GND point

ESD safe Field service kit

9.1.5 More information about ESD precautions. All precautions against ESD damage are described in the CECC 00015/I regulations, composed by the CECC (Cenelec electronic Components Committee).

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