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No. 2Y730-502E*C

MAINTENANCE MANUAL FOR DIAGNOSTIC ULTRASOUND SYSTEM / MODELS SSA-680A/SSA-660A (2Y730-502E*C)

© TOSHIBA MEDICAL SYSTEMS CORPORATION 2004-2009 ALL RIGHTS RESERVED

No. 2Y730-502E*C

IMPORTANT! 1. No part of this manual may be copied or reprinted, in whole or in part, without written permission. 2. The contents of this manual are subject to change without prior notice and without our legal obligation.

No. 2Y730-502E*C

REVISION RECORD REV.

DATE (MM/YY)

REASON /AUTHOR

PAGE CHANGED

Mr. Takahashi

-------

INI.

10/'04

*A

05/'06

Support of V5.0

Mr. Nakai P. 5-4

*B

08/'07

Addition of SSA-680A, Support of SSA-660A V6.0

P. 1-1, 1-3, 1-4, 5-4 to 5-6, 6-3 to 6-9, 8-3, Mr. Nakai A-1

*C

03/'09

Change of check procedure

Mr. Nakai P. 2-2

3

SER. No.

DOC. PRODUCT.

TM-WP7 TM-WP2

No. 2Y730-502E*C

Safety Precautions 1.

Meaning of Signal Words

In this manual, the signal words DANGER, WARNING, and CAUTION are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.

Signal word

Meaning

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Indicates a potentially hazardous situation which, if not avoided, may result in property damage.

CAUTION

2.

Meaning of Safety Symbols Symbol

Description Type-B applied part *

Type B when Type-B applied part is connected. The PCG sensor and pulse sensor that can be connected to this system are Type-B applied parts.

Type-BF applied part *

Type BF when Type-BF applied part is connected. All ultrasound transducers, ECG cables, and respiration sensors that can be connected to this system are Type-BF applied parts.

"Attention" (Refer to the operation manual.)

4

No. 2Y730-502E*C

3.

Safety Precautions

Please observe the following precautions to ensure the safety of service engineers as well as operators when using this system.

DANGER:

WARNING:

Do not use flammable gases such as anesthetics, or flammable liquids such as ethanol, near this product, because there is danger of explosion. If flammable or combustible gas is present in the room where the system is installed, ventilate the room by opening the windows or using other appropriate measures before turning the system power ON/OFF. If the system power is turned ON/OFF in a room containing flammable or combustible gas, an explosion may occur as a result of sparking at contacts in a relay circuit or circuit breaker.

1. Information concerning the terminal to which the potential equalization conductor is to be connected (

):

To use another medical device in combination with this system, an equipotential wire for connecting to an equipotential bus must be supplied. For more information, contact your TOSHIBA representative. *

Be sure to connect the potential-equalization lead wire before inserting the equipment power plug into the receptacle. Also, be sure to remove the equipment power plug from the receptacle before disconnecting the wire to avoid electrical shock.

2. Information concerning the functional earth terminal ( ): Use of the functional earth terminal as protective earth is not allowed in Europe. The system should be connected according to local requirements. 3. Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life-support systems. If this system malfunctions and generates an overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped. 4. Do not connect to the system transducers other than those specified by TOSHIBA, to prevent accidents such as fire. 5. Do not subject the transducers to knocks. Use of defective transducers may cause an electric shock.

5

No. 2Y730-502E*C

CAUTION: 1. Malfunctions due to radio waves (1) Use of radio-wave-emitting devices in the proximity of this kind of medical electronic system may interfere with its operation. Do not bring or use devices which generate radio waves, such as cellular telephones, transceivers, and radio controlled toys, in the room where the system is installed. (2) If a user brings a device which generates radio waves near the system, they must be instructed to immediately turn OFF the device. This is necessary to ensure the proper operation of the system. 2. Be sure to install the system on a level floor and lock the casters. If this is not done, the system may move, injuring the service personnel. 3. Move the system forward or backward only. If the system is moved to the left or right, it may fall, causing injury. 4. To prevent electric shock, do not connect the peripheral units (video printer, VCR, etc.) to an external outlet. Peripheral units should be connected to the service outlet of the system. For the connection procedures, contact your TOSHIBA representative. 5. The service outlet of the main unit is intended solely for recommended peripheral units. Do not connect devices other than recommended peripheral units to the service outlet. Connecting devices other than those recommended may cause the consumption current to exceed the power capacity of the main unit, possibly resulting in malfunction. 6. Do not place any objects on top of the monitor. They may fall, causing injury. 7. Do not allow fluids such as water to contact the system or peripheral devices. Electric shock may result. 8. Do not handle the system with wet or moist hands. Electric shock may result. 9. The monitor is a heavy unit. Two persons are required when mounting or removing the monitor. If a single person performs this work, he or she may get injured. 10. Be sure to turn OFF the power breaker, disconnect the mains plug from the outlet, and wait at least 30 seconds before removing the covers of the main unit and performing internal wiring or other work. 11. When discarding any part of this system, follow all applicable local regulations. 12. Wear protective gloves to ensure safety and prevent infection when performing unit replacement, board replacement, internal wiring, or cleaning. 13. Wait at least 30 seconds after turning OFF the power breaker and disconnecting the mains plug from the outlet before replacing the battery. Otherwise, an electric shock may result.

6

No. 2Y730-502E*C

CONTENTS Page Safety Precautions --------------------------------------------------------------------------------------------------------------- 4 1.

2.

OUTLINE -------------------------------------------------------------------------------------------------------------------- 9 1.1

Introduction--------------------------------------------------------------------------------------------------------- 9

1.2

Tools and Measuring Devices Required -------------------------------------------------------------------- 9

1.3

Inspection Schedule---------------------------------------------------------------------------------------------12

1.4

Check Before Inspection ---------------------------------------------------------------------------------------12

1.5

Inspection Results -----------------------------------------------------------------------------------------------13

1.6

Concerning Safety Checks ------------------------------------------------------------------------------------13

1.7

About the Inspection Notification Message----------------------------------------------------------------13

SYSTEM SELF-DIAGNOSIS ------------------------------------------------------------------------------------------14 2.1

3.

4.

5.

Diagnostics --------------------------------------------------------------------------------------------------------15

CHECK OF FUNCTIONS-----------------------------------------------------------------------------------------------16 3.1

Display of the Time and Date ---------------------------------------------------------------------------------17

3.2

Operation of the Trackball -------------------------------------------------------------------------------------17

3.3

Operation of the Fan --------------------------------------------------------------------------------------------17

CHECK OF MECHANICAL SAFETY --------------------------------------------------------------------------------18 4.1

Casters -------------------------------------------------------------------------------------------------------------19

4.2

Caster Attachment Sections ----------------------------------------------------------------------------------19

4.3

Monitor Mounting Mechanism --------------------------------------------------------------------------------19

4.4

Operating Panel --------------------------------------------------------------------------------------------------19

4.5

Mounting Mechanism for Peripheral Devices -------------------------------------------------------------19

4.6

Other Mechanical Parts ----------------------------------------------------------------------------------------19

4.7

External Appearance and Connections of the Cables --------------------------------------------------19

4.8

External Appearance of the Transducer -------------------------------------------------------------------19

CLEANING -----------------------------------------------------------------------------------------------------------------20 5.1

Interior of the System/Fan -------------------------------------------------------------------------------------21

5.2

Filter-----------------------------------------------------------------------------------------------------------------21

7

No. 2Y730-502E*C

CONTENTS - continued Page

6.

7.

8.

9.

5.3

Covers/Panels ----------------------------------------------------------------------------------------------------23

5.4

Touch Panel-------------------------------------------------------------------------------------------------------23

5.5

Monitor -------------------------------------------------------------------------------------------------------------23

5.6

Transducer/Transducer Holder/Gel Holder----------------------------------------------------------------25

5.7

Video Printer (Option)-------------------------------------------------------------------------------------------25

5.8

MO Drive (Option) -----------------------------------------------------------------------------------------------25

5.9

CD-R Drive --------------------------------------------------------------------------------------------------------25

5.10

Cables/Cords -----------------------------------------------------------------------------------------------------25

CHECK OF ELECTRICAL SAFETY ---------------------------------------------------------------------------------26 6.1

Protective Conductor Resistance ----------------------------------------------------------------------------28

6.2

Ground Line Leakage Current --------------------------------------------------------------------------------32

6.3

Enclosure Leakage Current -----------------------------------------------------------------------------------32

6.4

Patient Leakage Current I -------------------------------------------------------------------------------------32

6.5

Patient Leakage Current III------------------------------------------------------------------------------------33

6.6

Patient Auxiliary Current ---------------------------------------------------------------------------------------34

CHECK OF 2D MODE AND RECORDING OF IMAGES -------------------------------------------------------35 7.1

Lateral Resolution/Axial Resolution -------------------------------------------------------------------------36

7.2

Penetration --------------------------------------------------------------------------------------------------------36

7.3

Speckle Characteristics ----------------------------------------------------------------------------------------36

7.4

Recording of Images --------------------------------------------------------------------------------------------36

REPLACEMENT OF PARTS ------------------------------------------------------------------------------------------37 8.1

Replacing the Battery -------------------------------------------------------------------------------------------38

8.2

Charging the Battery --------------------------------------------------------------------------------------------40

8.3

Replacing the Battery for the ATX Board ------------------------------------------------------------------40

VCR RECORDING -------------------------------------------------------------------------------------------------------45

PERIODIC INSPECTION CHECK SHEET --------------------------------------------------------------------------------47

8

No. 2Y730-502E*C

1. 1.1

OUTLINE Introduction This manual describes the maintenance and inspection procedures for the diagnostic ultrasound system SSA-680A/SSA-660A.

1.2 1.2.1

1.2.2

Tools and Measuring Devices Required Phantoms and measuring devices Product name

Type

Phantom for checking axial and lateral resolution

000021

Manufacturer CARDIFF

Specifications/standards Specified type only allowed

Documents Product name

Type

Maintenance manual

SSA-680A, SSA-660A: 2Y730-502E

Service manual

SSA-680A, SSA-660A (V6.00 or later): 2D730-519EN SSA-660A (V5.00 or earlier): 2D730-502E SSA-680A, SSA-660A (V6.00 or later): 2D730-520EN SSA-660A (V5.00 or earlier): 2D730-503E

9

Specifications/standards

No. 2Y730-502E*C

1.2.3

Tools, measuring devices, and consumables for the diagnostic ultrasound system Tool/measuring device

Q'ty

Remarks

Testing device for electrical safety check

1 set

Toshiba-specified type

Ground circuit tester

1 set

Toshiba-specified type

Resin container or stainless container

1

Large enough to accommodate two transducer heads

Vinyl bags

1

Approx. 2 m × 2 m (0.3 mm thick)

Rubber gloves

1 pair

Vacuum cleaner

1

Blower (600W 0 to 16000 mm/min)

1

Makita 4014NV or equivalent

Brush

1

As small as a toothbrush

Air spray or blower brush

1

MO drive head cleaner

1

Fujitsu: Product No. 0240470, Drawing No. CA90002-C980

Q'ty

Remarks

Cleaner

Consumable parts Aluminum foil

1

Physiological saline solution (0.85 to 0.95% saline solution)

⎯

Glass cleaner

1

For cleaning the CRT monitor

Soft cotton cloth or lens cleaning paper

1

For cleaning the LCD surface

Mild detergent

The saline container should be filled.

For cleaning the LCD monitor cover and touch panel

Neutral detergent Rag

CAUTION: 1. Do not use hydrocarbon glass cleaner or cleaner for the OA equipment to clean the monitor. This substance may cause deterioration in the monitor. 2. Do not use solvents (such as paint thinner or benzine) or abrasive cleansers for cleaning the unit. These substances may cause deterioration in the monitor.

10

No. 2Y730-502E*C

1.2.4

Standard set of tools, consumables Tool

Type

Manufacturer

Specifications/standards

Screwdriver (various sizes and types)

(Not specified)

Stubby Phillips screwdriver (large)

(Not specified)

Wire nipper

(Not specified)

Needle nose pliers

(Not specified)

Diagonal pliers

(Not specified)

Soldering iron, stand

(Not specified)

Desoldering tool

(Not specified)

Wrench set

(Not specified)

Adjustable wrench

(Not specified)

Tweezers

(Not specified)

Hammer

(Not specified)

Metric Allen wrench set

(Not specified)

File (various types)

(Not specified)

Cutter

(Not specified)

Consumables

Type

Manufacturer

Specifications/standards

Insulation tape

(Not specified)

Hishilite tube, Empire tube (various types)

(Not specified)

Wiring material (various types)

(Not specified)

Screws, nuts, washers (various types)

(Not specified)

Solder

(Not specified)

Paper file (various types)

(Not specified)

Ethanol for cleaning and disinfection

(Not specified)

11

No. 2Y730-502E*C

1.3

Inspection Schedule The prescribed inspection schedule for the first year after installation is shown below. Model

Inspection schedule 12 months after installation

SSA-680A/ SSA-660A

Remarks Basically the system should be inspected every year. Clean it depending on its condition or the system environment.

c

The contents of contract-based inspections made subsequent to the first year after installation differ depending on the maintenance contract. The relevant service company must determine the contents and intervals of such inspections. 1.4 1.4.1

Check Before Inspection Checking the system conditions Check the items below with the user or in the log book to understand the system conditions.

1.4.2

(1)

The occurrence of anything out of the ordinary while the system is in operation

(2)

Abnormalities occurring intermittently

(3)

History of problems

(4)

Requests from the user

Checking the operating environment Check the temperature and humidity in the examination room. Measurements related to electric safety are particularly sensitive to the humidity. These measurements are also sensitive to the measurement location and measurement circuit. If the insulation characteristics deteriorate due to system changes over time or system malfunctions, the measurement fluctuations are likely to increase with the increase in humidity.

1.4.3

Checking the system settings Check the preset conditions of the system, brightness and contrast of the monitor, and options including the transducer. Make a hard copy of the preset conditions used normally and file it in the log book.

1.4.4

Checking the system version Check the system version in the service menu.

1.4.5

Checking the system operation Check the system operation.

12

No. 2Y730-502E*C

1.5

Inspection Results If any abnormalities are found in the inspection, instruct the user to stop using the system and to request repair.

1.6

Concerning Safety Checks The items shown in section 4 "CHECK OF MECHANICAL SAFETY", those shown in section 6 "CHECK OF ELECTRICAL SAFETY", and the item 5.2 "Filter" in section 5 "CLEANING" are applicable.

1.7

About the Inspection Notification Message The following message is displayed when the period of operation (factory setting: 600 hours) set in the system has elapsed. The interval for display of this message can be changed. For details, refer to the service manual. The maintenance period coming. Please contact your service representative.

13

No. 2Y730-502E*C

2.

SYSTEM SELF-DIAGNOSIS • Inspection procedure Perform system self-diagnosis using Test Tools in the service menu. • Flowchart of the inspection process Diagnostics tests

14

No. 2Y730-502E*C

Item Self-diagnosis

Code A01

Inspection contents 2.1 Diagnostics

Procedures (1) Start up the system with no transducers connected. Display the service menu and select [Test Tools] → [Diagnostics]. (2) Select "TI", "TX", "RX", and "RC" in the [Test Tools Diagnostics] window and click [Execute]. (3) Confirm that all items in the Result column are "OK".

15

Tools

Corrective actions and parts to be replaced

No. 2Y730-502E*C

3.

CHECK OF FUNCTIONS • Flowchart of the work process Display the time and date. Operate the trackball. Operate the fan.

16

No. 2Y730-502E*C

Item Functions

Code

Inspection contents

B01

3.1 Display of the Time and Date

Procedures (1) Confirm that the time and date displayed on the monitor are correct. (2) If they are incorrect, correct them.

B02

3.2 Operation of the Trackball

(1) Set "Measurement" to ON. (2) Operate the measurement caliper vertically and horizontally using the trackball. Confirm that the caliper moves smoothly.

B03

3.3 Operation of the Fan

(1) Confirm that the fan installed in the main unit rotates when the main unit power is turned ON. (2) Confirm that the fan makes no abnormal sounds when it rotates.

17

Tools

Corrective actions and parts to be replaced

No. 2Y730-502E*C

4.

CHECK OF MECHANICAL SAFETY • Evaluation Evaluation is performed by visual and operational checks. • Flowchart of check procedures Check the casters. Check caster attachment sections. Check the monitor mounting mechanism. Check the operating panel. Check the peripheral device mounting mechanisms. Check the other mechanical parts. Check the external appearance and connections of each cable. Check the external appearance of the transducer. If any of the check results are unacceptable, the system is abnormal. Stop using the system and take appropriate measures.

18

No. 2Y730-502E*C

Item Mechanical safety

Code

Inspection contents

Procedures

C01

4.1 Casters

Confirm that the four casters are straight and free from excess play. Also, confirm that the caster lock/unlock mechanism functions correctly.

C02

4.2 Caster Attachment Sections

When the system is used at a site in which the system is moved frequently or moved over a route with many differences in level, confirm that the caster attachment sections of the chassis are not distorted or cracked. * If the system cannot be moved smoothly in the straight direction, there is possibility of an abnormality such as distortion or cracks in casters or caster attachment sections.

C03

4.3 Monitor Mounting Mechanism

(1) Confirm that the monitor is not tilted and does not show excessive play. (2) Confirm that the monitor can be moved and swiveled normally.

C04

4.4 Operating Panel

Confirm that the panel is not tilted and does not show excessive play.

C05

4.5 Mounting Mechanism for Peripheral Devices

Confirm that the peripheral devices are mounted correctly.

C06

4.6 Other Mechanical Parts

Confirm that the suspension mechanism and the external panels are free from abnormalities.

C07

4.7 External Appearance and Connections of the Cables

(1) Confirm that the cables do not have any cracks or damage. (2) Confirm that the connector for each cable is fixed securely in the unit. (3) Confirm that the cables are grounded correctly.

C08

4.8 External Appearance of the Transducer

Confirm that the transducers do not have any cracks, peeling, looseness of parts, or damage. If a TEE transducer is used, perform the insulation resistance test. (Refer to the safety kit operation manual supplied with the transducer.)

19

Tools

No. 2Y730-502E*C

5.

CLEANING • Flowchart of cleaning process Disconnect the power cable from the outlet. Remove the accessories. Remove the covers of the main unit and monitor. Clean the interior of the system and the fan. Clean the filter. Clean the covers and panels. Clean the monitor. Clean the transducer, transducer holder, and gel holder. Clean the peripheral devices and accessories. Clean the power supply cord and the cables.

20

No. 2Y730-502E*C

Item Cleaning

Code D01

Inspection contents 5.1 Interior of the System/Fan

Procedures (1) Disconnect the power plug from the outlet.

Tools Phillips screwdriver

(2) Remove accessories such as the transducer, transducer holder, printer, and VCR from the main unit. (3) Remove the monitor cover. (4) Remove the covers of the main unit so that the PWBs and the interior of the power supply are visible. Do not remove any PWBs unless it is abnormal. (5) Cover the main unit with a big vinyl bag.

Vinyl bag Size 2 × 2 m

(6) Put the nozzle of the vacuum cleaner in the vinyl bag and turn it ON to vacuum dust.

Vacuum cleaner

(7) On the vinyl bag, make an opening as large as can allow the nozzle of the blower to be inserted and blow out dust on the monitor, fan, PWBs, rack, power supply, etc. from top to bottom.

Blower Makita 4014NV 600W 0 to 16000 mm/min

(8) Remove the vinyl bag gently, taking care not to spread the dust on the inner surface of the bag. (9) Vacuum all remaining dust with the vacuum cleaner. D02

5.2 Filter

(1) Cleaning the air filters of the rack section (a) Remove the air filters from the cover. (b) Remove dust from the mesh grids using a vacuum cleaner at a location away from the system. (c) Insert the air filters fully into the slots in the cover.

21

Vacuum cleaner

No. 2Y730-502E*C

Item Cleaning

Code D02

Inspection contents 5.2 Filter

Procedures

Tools

(2) Cleaning the air filters of the power supply unit (a) Remove the Velcro tapes and remove the air filters from the unit. (b) Remove dust from the mesh grids using a vacuum cleaner at a location away from the system. (c) Reinstall the air filters at their original locations and secure them with the Velcro tapes.

Slot Air filter of the rack section Velcro tape

Slot Air filter of the power supply unit

CAUTION:

Do not start the system with the filters removed.

22

No. 2Y730-502E*C

Item Cleaning

Code

Inspection contents

Procedures

D03

5.3 Covers/Panels

Wipe the covers and panels gently using a piece of soft dry cloth. If necessary, spray neutral detergent onto a piece of soft, finely woven cloth and use it to clean the covers and panels. Use cotton swabs to clean areas around the switches and keys on the main panel.

D04

5.4 Touch Panel

Clean the surface sheet using a commercially available eyeglass cleaning cloth (non-woven rayon cloth etc.) or a soft dry cloth. If necessary, use a piece of soft cloth moistened with a small amount of ethyl alcohol.

D05

5.5 Monitor

(1) CRT Monitor Wipe the surface of the monitor and the cover. Spray glass cleaner onto a piece of soft, finely woven cloth and use it to clean the monitor gently. (2) LCD Monitor Monitor :

Use a soft cotton cloth or lens cleaning paper to clean the LCD surface.

Cover :

Clean the monitor cover using a soft cloth moistened with mild detergent.

23

Tools

No. 2Y730-502E*C

Item

Code

Inspection contents

Procedures

CAUTION: 1. Do not hit or apply strong pressure to the LCD surface during cleaning. Doing so may damage the monitor. 2. Never use a stiff or hard cloth to clean the LCD monitor. Doing so may damage the monitor cover or LCD surface. 3. If stains on the LCD surface are difficult to remove, wipe it gently with a soft cloth slightly moistened with water. Detergents or chemical agents should not be used because they may damage the monitor. 4. Do not attempt to clean the LCD monitor with organic solvents such as benzine, paint thinner, and alcohol or abrasive cleaners. Such agents may damage the monitor cover or LCD surface. Also, do not use mild detergent to clean the LCD surface. 5. Do not allow liquid droplets to remain on the LCD surface. The droplets may cause small stains when they dry or may enter the LCD surface, possibly resulting in failure.

24

Tools

No. 2Y730-502E*C

Item Cleaning

Code

Inspection contents

Procedures

D06

5.6 Transducer/ Transducer Holder/ Gel Holder

Clean the transducers according to the operation manual supplied with each transducer. Clean the transducer holder and gel holder with a piece of soft dry cloth. If necessary, use a piece of soft cloth moistened with water.

D07

5.7 Video Printer (Option)

Clean the thermal head of the printer according to the operation manual for the printer.

D08

5.8 MO Drive (Option)

Clean the MO drive using the MO drive head cleaner.

D09

5.9 CD-R Drive

Clean the CD-R drive according to the operation manual provided with the CD-R unit.

D10

5.10 Cables/Cords

Wipe off all dirt from the main unit power supply cord and the signal cables using neutral detergent.

25

Tools Toothbrush-size brush Blower brush or LPG gas spray Phillips screwdriver

Neutral detergent

No. 2Y730-502E*C

6.

CHECK OF ELECTRICAL SAFETY • Check procedures For the measurements below, use the Toshiba-specified measuring devices such as the testing device for electrical safety check, type ESA-1. For details of the items below, refer to the maintenance and inspection manual (2Y549-903E). • Flowchart of check procedures Measure the protective conductor resistance. Measure the ground line leakage current. Measure the enclosure leakage current. Measure patient leakage current I. Measure patient leakage current III. Measure the patient auxiliary current. If any of the check results are unacceptable, the electrical safety of the system is not ensured. Stop using the system and take appropriate measures. If the check result for patient leakage current III does not meet the standard, replace the sensors.

26

No. 2Y730-502E*C

• Measurement procedure for items 6.2 to 6.6 1. Measure the ground line leakage current, enclosure leakage current, patient leakage currents I and III, and the patient auxiliary current with normal power input polarity A (normal condition A). Patient leakage current III must be measured with each of the applied voltage polarities A' and B'. 2. Turn the protective grounding OFF using the testing device (single fault condition A), and measure the enclosure leakage current, patient leakage current I, and the patient auxiliary current. 3. Turn OFF the power switch and the breaker of the system, and turn OFF power output polarity A using the testing device. Turn ON the protective grounding. Then, turn ON the breaker (single fault condition B) and measure the ground line leakage current, enclosure leakage current, patient leakage current I, and the patient auxiliary current. 4. Turn OFF power output polarity B using the testing device (single fault condition C). Measure the ground line leakage current, enclosure leakage current, patient leakage current I, and the patient auxiliary current. 5. Turn the system breaker OFF. Turn ON the breaker and power switch of the system (normal condition B) with power input polarity B of the testing device. Measure the ground line leakage current, enclosure leakage current, patient leakage currents I and III, and the patient auxiliary current. Patient leakage current III must be measured with each of the applied voltage polarities A' and B'. 6. Turn the protective grounding OFF using the testing device (single fault condition D), and measure the enclosure leakage current, patient leakage current I, and the patient auxiliary current. Power input polarity

Power conducting wires

Protective grounding wire

Normal condition A

A

Connected

Connected

Normal condition B

B

Connected

Connected

Single fault condition A

A

Connected

Broken

Single fault condition B

A

Single wire broken

Connected

Single fault condition C

B

Single wire broken

Connected

Single fault condition D

B

Connected

Broken

27

No. 2Y730-502E*C

Item

Code

Electrical safety

E01

Inspection contents 6.1 Protective Conductor Resistance

Procedures

Tools

Perform measurements while the system is not in operation. From the transducer hanger mounting screw to the ground pin of the 3-pin power plug of the system.

0.2 Ω or less

Measurement points for the protective conductor resistance check (SSA-680A)

Protective ground circuit tester

28

No. 2Y730-502E*C

Item

Code

Inspection contents

Procedures Measurement points for the protective conductor resistance check (SSA-660A)

Protective ground circuit tester

29

Tools

No. 2Y730-502E*C

Item

Code

Inspection contents

Procedures

Tools

Mesurement points for the ground line leakage current check (SSA-680A) Testing devise for the electrical safty check Electrical outlet

ECG terminal A B

C1

B1,C1,E1,F1 G1,G2. G1 E1 G2 F1

G1 G2

30

No. 2Y730-502E*C

Item

Code

Inspection contents

Procedures

Tools

Mesurement points for the ground line leakage current check (SSA-660A) Testing devise for the electrical safty check Electrical outlet

ECG terminal A B

C1

B1,C1,E1,F1 G1,G2. G1 E1 G2 F1

G1 G2

31

No. 2Y730-502E*C

Item

Code

Electrical safety

E02

E03

E04

Inspection contents 6.2 Ground Line Leakage Current

6.3 Enclosure Leakage Current

6.4 Patient Leakage Current I

Procedures Perform measurements while the system is in operation.

Tools Normal: 0.5 mA or less

(1) Connect the 3-pin power plug of the system to the outlet on the testing device for the electric safety check (referred to hereinafter as testing device) (B1).

Single fault: 1 mA or less

Perform measurements while the system is in operation.

Normal:

(1) Connect the transducer hanger mounting screw to the testing device with the supplied cable and connect the 3-pin power plug of the system to the outlet on the testing device (C1). Perform the following measurements while the system is in operation. (1) Wrap the transducer with aluminum foil and place it in a container filled with physiological saline solution. Connect the aluminum foil to measuring point A on the testing device with the supplied cable and connect the 3-pin power plug of the system to the outlet on the testing device (E1). CAUTION:

There must be some physiological saline solution between the transducer and the aluminum foil.

(2) Wrap the electrode and sensors listed below separately with aluminum foil. Connect each aluminum foil to measurement point A on the testing device with the supplied cable, and connect the 3-pin power plug of the system to the outlet on the testing device. (a)

ECG electrode

(b)

PCG sensor

(c)

Pulse wave sensor

(d)

Respiration sensor

32

0.1 mA or less Single fault: 0.5 mA or less Normal: AC 0.1 mA or less DC 0.01 mA or less Single fault: AC 0.5 mA or less DC 0.05 mA or less

No. 2Y730-502E*C

Item

Code

Electrical safety

E05

Inspection contents 6.5 Patient Leakage Current III

Procedures Perform the following measurements while the system is in operation.

Tools Single fault: 5 mA or less

(1) Wrap the transducer with aluminum foil and place it in a container filled with physiological saline solution. Connect the aluminum foil to measuring point A on the testing device with the supplied cable and connect the 3-pin power plug of the system to the outlet on the testing device (F1). (2) Wrap the electrode and sensors listed below separately with aluminum foil. Connect each aluminum foil to measurement point A on the testing device with the supplied cable, and connect the 3-pin power plug of the system to the outlet on the testing device. (a) ECG electrode (b) PCG sensor (c) Pulse wave sensor (d) Respiration sensor

CAUTION: An AC voltage that is 10% greater than the line voltage is applied to the electrodes and sensors. Follow the instructions below to prevent an electric shock. (1)

Do not perform measurements with moist hands.

(2)

Do not allow other persons to come close to the sensors during measurement.

(3)

Connect the testing device securely with aluminum foil. The aluminum foil should enclose the electrode or sensor.

33

No. 2Y730-502E*C

Item

Code

Inspection contents

Electrical safety

E05

6.5 Patient Leakage Current III

E06

6.6 Patient Auxiliary Current

Procedures CAUTION:

Tools

There must be some physiological saline solution between the transducer and the aluminum foil.

Perform the following measurements while the system is in operation. (1) Wrap the transducer with aluminum foil and connect the aluminum foil to measuring point A on the testing device with the supplied cable. In addition, wrap each electrode of the ECG with aluminum foil and further wrap them together with aluminum foil. Then, connect the aluminum foil to measuring point B on the testing device with the supplied cable (G1). Connect the 3-pin power plug of the system to the outlet on the testing device. (2) Wrap the electrodes of the ECG with aluminum foil and connect one electrode to measuring point A and the other to measuring point B on the testing device (G2). Connect the 3-pin power plug of the system to the outlet on the testing device.

34

Normal: AC 0.1 mA or less DC 0.01 mA or less Single fault: AC 0.5 mA or less DC 0.05 mA or less

No. 2Y730-502E*C

7.

CHECK OF 2D MODE AND RECORDING OF IMAGES • System settings Use the factory settings for items other than those described in this manual. If any settings are changed for special reasons, record the settings as supplementary information. • Recording and filing images Print images and file them together with the recorded data. • Flowchart of check procedures Check the lateral resolution and axial resolution. Check the penetration. Check the speckle characteristics. Record images and check them. *

Perform the inspections shown above for all transducers used by the user.

35

No. 2Y730-502E*C

Item Checking 2D mode and recording images

Code F01

Inspection contents 7.1 Lateral Resolution/Axial Resolution

Procedures (1) Spread ultrasound gel on the phantom and apply the transducer to it. (2) Apply the transducer to the phantom so that the resolution of the wire target is optimal. (3) When the optimal image is obtained, freeze the image and record it. (In DUAL-display mode, print out the image together with the penetration image, which is obtained as described below.)

F02

7.2 Penetration

(1) Spread ultrasound gel on the phantom and apply the transducer to it. (2) Adjust the GAIN and STC so that the speckle for the parenchyma is displayed at the deepest position. (3) Measure the depth at the border between the noise and parenchyma and record an image on which the measured depth is displayed.

F03

7.3 Speckle Characteristics

Evaluate the changes over time by periodically recording the images as described above.

F04

7.4 Recording of Images

File the images printed according to the procedure described above.

36

Tools

No. 2Y730-502E*C

8.

REPLACEMENT OF PARTS Replace the periodically replaced parts. Periodically replaced part

Replacement interval

Battery

1 year

Battery for the ATX board

1 year

CAUTION: Wait at least 30 seconds after turning OFF the power breaker and disconnecting the mains plug from the outlet before replacing the battery. Otherwise, an electric shock may result.

37

No. 2Y730-502E*C

Item

Code

Inspection contents

Replacement of parts

G01

8.1 Replacing the Battery (Replacement interval: 1 year)

Procedures CAUTION: Do not perform this work in the standby status. (1) Open the printer tray and remove one M4 screw . (2) Remove one cap and remove one M4 screw . (3) Remove one cap and remove one M4 screw . (4) Remove the caps and (one each) and loosen two M4 screws . (5) Slide the left side cover toward the front and open it from the rear to remove it. (6) Remove the connector that is connected to the battery and remove the battery.

38

Tools

No. 2Y730-502E*C

Item

Code

Replacement of parts

G01

Inspection contents

Procedures

Tools

8.1 Replacing the Battery Screw (SBPP4-10SCR)

Battery

Cap Printer tray Operation check LED Cap Screw (SBPP4-10SCR)

Cap

Left side cover

Cap

39

Screw (SBPP4-12SCR)

Screw (SBPP4-10SCR)

No. 2Y730-502E*C

Item

Code

Replacement of parts

G02

Inspection contents 8.2 Charging the Battery

Procedures (1) Connect the power plug to the outlet. (2) Turn ON the circuit breaker. (a) Charging starts automatically. (b) The operation check LED (segment LED) blinks. (c) Charging stops after 2 hours. (d) To charge the battery fully, turn the circuit breaker OFF and then ON again. (3) After charging has been completed, confirm that the operation check LED (segment LED) is lit. NOTE:

G03

8.3 Replacing the Battery for the ATX Board

If the breaker is set to OFF, the battery discharges and recharging is required.

(1) Remove the CPU assy. CAUTION: Do not perform this work in the standby status. (a) Shut down the system. If the system is ON :

Shut down the system.

If the system is OFF :

Start the system and then, after it has started up normally, shut it down.

(b) Turn OFF the breaker of the system. (c) Remove the USB cable if required and then remove the CPU assy.

40

Tools

No. 2Y730-502E*C

Item

Code

Replacement of parts

G03

Inspection contents 8.3 Replacing the Battery for the ATX Board

Procedures

Tools

(2) Replace the battery. (a) Remove the battery near the IDE connector on the ATX board (refer to the figure below). (b) Replace the battery with the new one.

Battery (CR2032)

41

No. 2Y730-502E*C

Item

Code

Replacement of parts

G03

Inspection contents 8.3 Replacing the Battery for the ATX Board

Procedures (3) Remove the HDD unit. CAUTION: Set the date and time on the BIOS setting screen before reinstalling the HDD unit. If the system is started without setting the date and time on the BIOS setting screen, the initial setting time on the CPU board is set as the system time. (4) Start the system. (a) Install the CPU board in the system. Connect the USB cable if it was removed. (b) Turn ON the breaker of the system. (c) Press the power switch. (The power supply may be turned ON again after it is turned OFF.) (d) Press the [Delete] key while the logon screen is displayed. The BIOS setting screen is displayed.

42

Tools

No. 2Y730-502E*C

Item

Code

Replacement of parts

G03

Inspection contents 8.3 Replacing the Battery for the ATX Board

Procedures (5) Perform BIOS setting. (a) Check the date displayed on the main page and change it if necessary. "Date": Enter the date in the order month, day, year. (The day of the week is automatically determined.) "Time": Enter the time in the order hours, minutes, seconds (24-hour time format).

• Selecting the page Use the left and right arrow keys [←] and [→] to display the page. • Selecting the main item Use the up and down arrow keys [↑] and [↓] to select "Date" or "Time". • Selecting the specific item in the main item Press the [Enter] key to select each item in the order month, day, year or in the order hours, minutes, seconds. • Changing the value for the item (day, year, hours, minutes, seconds) Press [PageUp]/[PageDown] to increase/decrease the value and then press the [Enter] key. It is also possible to set the value by entering it directly from the keyboard and then pressing the [Enter] key. • Changing the value for the item (month) Press [PageUp]/[PageDown] to change the name of the month (for example, Jan. → Feb. → Mar.). After selecting the month name, press the [Enter] key.

43

Tools

No. 2Y730-502E*C

Item

Code

Replacement of parts

G03

Inspection contents 8.3 Replacing the Battery for the ATX Board

Procedures (b) Load the default settings. Press the right arrow key [→] to select the EXIT page. Press the down arrow key [↓] to select "Load Optimized Default". Press the [Enter] key. A confirmation message is displayed. Enter "y" (yes) and then press the [Enter] key. When loading is completed, the previous screen is displayed again. (c) Save the settings. Select "Save & Exit Setup" on the EXIT page and then press the [Enter] key. A confirmation message is displayed. Enter "y" (yes) and press the [Enter] key. The system restarts automatically. Confirm that the message "OS not found" is displayed and then terminate the system by holding down

POWER

for at least 5 seconds.

(6) Reinstall the HDD unit. (7) Start the system again. Confirm that the system starts normally and then shut it down.

44

Tools

No. 2Y730-502E*C

9.

VCR RECORDING Perform the following checks to ensure that the VCR is ready for recording and playback (Code: H01).

The vertical and horizontal scales of a stored image are measured using the manual calibration function. (1)

Start the system and connect a body-surface transducer such as the PVT-375BT to the system. Display a 2D-single image and set the DEPTH to 20 cm. Record the image on the VCR.

(2)

Play back the recorded image. Using the manual calibration function, set a calibration marker 100 mm in length using the vertical scale as the reference and enter the length of the calibration marker in the box on the right of [2D Distance]. Measurement becomes possible.

45

No. 2Y730-502E*C

(3)

Measure the distance corresponding to 10 graduations on the horizontal scale and confirm that the error is within ±5% of the distance set on the vertical scale (95 mm to 105 mm).

(4)

If the error is more than ±5%, set the calibration marker again carefully. If the error is still greater than ±5%, check with the user whether the error is acceptable for the intended use. If the error is not acceptable, instruct the user not to use the results.

46

No. 2Y730-502E*C

PERIODIC INSPECTION CHECK SHEET Item

No.

Inspection contents

Result

System self-diagnosis

A01

Diagnostics

† OK

† NG

Check of functions

B01

Display of the time and date

† OK

† NG

B02

Operation of the trackball

† OK

† NG

B03

Operation of the fan

† OK

† NG

C01

Casters

† OK

† NG

C02

Caster attachment sections

† OK

† NG

C03

Monitor mounting mechanism

† OK

† NG

C04

Operating panel

† OK

† NG

C05

Mounting mechanism for peripheral devices

† OK

† NG

C06

Other mechanical parts

† OK

† NG

C07

External appearance and connections of the cables

† OK

† NG

C08

External appearance of the transducer

† OK

† NG

D01

Interior of the system/fan

† OK

† NG

D02

Filter

† OK

† NG

D03

Covers/panels

† OK

† NG

D04

Touch panel

† OK

† NG

D05

Monitor

† OK

† NG

D06

Transducer/transducer holder

† OK

† NG

D07

Video printer

† OK

† NG

D08

MO drive

† OK

† NG

D09

CD-R drive

† OK

† NG

D10

Cables/cords

† OK

† NG

E01

Protective conductor resistance

† OK

† NG

E02

Ground line leakage current

† OK

† NG

E03

Enclosure leakage current

† OK

† NG

E04

Patient leakage current I

† OK

† NG

E05

Patient leakage current III

† OK

† NG

E06

Patient auxiliary current

† OK

† NG

F01

Lateral resolution/axial resolution

† OK

† NG

F02

Penetration

† OK

† NG

F03

Speckle characteristics

† OK

† NG

F04

Recording of images

† OK

† NG

G01

Replacing the battery

† OK

† NG

G02

Charging the battery

† OK

† NG

G03

Replacing the battery for the ATX board

† OK

† NG

H01

VCR recording

† OK

† NG

Mechanical safety

Cleaning

Electrical safety

Checking 2D mode and recording images

Replacement of parts

VCR recording

47

E

LEGAL MANUFACTURER

1385, SHIMOISHIGAMI, OTAWARA-SHI, TOCHIGI-KEN 324-8550, JAPAN "Made for Life" is a trademark of Toshiba Medical Systems Corporation.