MN2-2046 Rev.

0
Chapter 3 INSTALL/DISASSEMBLE

No.
Parts Name Appearance Quantity
:
14 Hexagonal wrench 1
/ Size:4mm (For Monitor Arm)

:
15 Hexagonal wrench 1
/ Size:3mm (For Probe Holder-2)

User Manual
16 · Safety Instruction -------- 1 set
· How to Use
· Measurement

17
Installation Procedures
-------- 1

18 -------- 1
Test Certificate

CONTENTS

1. 1. Fixing of Monitor

2. 2. Installation of Recorder

2-1. 2-1. Removing of Covers

2-2. 2-2. Installation of B/W Printer

3. 3. Operating of Panel moving (up-and-down)

4. 4. Installation of Probe Holder

5. 5. Installation of Cable Hook

6. 6. Operating of Caster-lock

7. 7. Operating of Monitor moving and Arm moving

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1. 1. Fixing of Monitor

Fixing of Monitor

HB5×20 SUS, 2 : Reuse

Fixture

Remove the belt and the cushion over the

monitor.

Unfasten 2 bolts and remove the fixture.

Cushion

Raise the monitor arm, and remove the cushion

under the monitor.
Do not drop the monitor when raising it.
The monitor is heavy and the base part of the
monitor arm is free. So handle it with care.
Raise the monitor arm by holding the arm and
the monitor upper part. Because, when raising
the monitor arm, the monitor may move.
Monitor arm Be careful not to pinch the cable.

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Fix the monitor arm with 2 bolts that are removed

at step as well.
Fix the bolts tightening it with long shaft of the
hexagonal wrench and make sure that the bolt are
firmly fixed.

Long shaft

HB5×20 SUS, 2
:
Use the bolt removed at

Monitor

Slide the monitor up to the top then tilt the

monitor upwards.

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2
Monitor arm
cover
1

Put the monitor arm cover by insert the hooks

into the slit of monitor arm base, then passing the
Monitor arm
cable through the slit of monitor arm cover.
base
Line up the monitor cables to make it passing
through the slit smoothly.

Fix the monitor arm cover with 2 accessory

screws.

BNK3×8 Fe-Ni, 2

Keep the cushion and the belt and

the fixture for reusing it when
transporting the SSD-PROSOUND4.

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2. 2. Installation of Recorder

2-1. 2-1. Removing of Covers

Removing of Covers

Right side cover

4

BNK3×10 Fe-Ni, 4

Unfasten 4 screws, and lift and remove the right

and left side covers as in the figure.

Left side cover

10

BNK3×8 Fe-Ni, 10

Loosen 10 screws, and lift and remove the

right shield cover as in the figure.

Shield cover

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1
1 1
Blindfold Board (1) (Not re-use)

Loosen 1 screw, and remove the blindfold board

(1). (Not re-use)

Tighten screws which loosened at

process

BNK3×8 Fe-Ni, 1

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2-2. 2-2. Installation of B/W Printer

Installation of B/W Printer

SSZ-310/ UP-897MD
In the case of SSZ-310/ UP-897MD
4

Fix the fixture to the printer with 4 accessory

screws.

Fixture

BNK3×6 Fe-Ni, 4

P-93
In the case of P-93
SSZ-310/ UP-897MD
Screw position of SSZ-310/ UP-897MD

Fixture
P-93
Screw position of P-93

BNK3×6 Fe-Ni, 4

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460mm

280mm

(YJ-150)

<Tidy up the power cable>

Clamp position

Secure the length of power cable as in the figure,

and arrange it.
Power cable

Bundle the arranged power cable to the cable

fastening plate by the accessory plastic cable
clamp (YJ-150) as in the figure.

Cable fastening plate

(YJ-150)
Plastic cable clamp (YJ-150)

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AC

200V AC

Connect the power cable to the AC outlet, pass

the another side of power cable through the
square hole, and tidy up it to the printer base.
(Refer to Cable Connection Procedure)

Connect the cables to AC outlet for 200V as in

the figure.

Power cable

200V AC
AC outlet for 200V

AC
AC outlet Power cable

Clamp position
Signal cable

430mm

<Tidy up the signal cable and control cable>

150mm
Secure the length of signal cable and accessory
control cable as in the figure, and arrange it.
Control cable

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(T18R)

T18R
Plastic cable clamp T18R

Cable fastening plate

Control cable Bundle the arranged cables to the cable fastening

plate by the accessory plastic cable clamp (T18R)
as in the figure.

Connect the signal cable and accessory control

cable to the connector panel, pass the another
side of cables through the square hole, and tidy
up it to the printer base.
(Refer to Cable Connection Procedure)

Signal cable

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Control cable

Connect all cables to the rear of printer.

(Refer to Cable Connection Procedure)

Power cable Signal cable

2
Printer

Insert the printer, and install it with 2 accessory

screws.

Be careful not to pinch the cable, when inserting

the printer.
Install the fixture upwards, when tightening the
screws.

BNK4×10 Fe-Ni, 2

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Chassis
Back of printer

Insert the extra cables of the rear of printer

between the printer and the chassis.

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Cable Connection Procedure

Carry out wiring in accordance with the chart below.

Recorder SSD-PROSOUND 4
VIDEO IN VIDEO OUT
SSZ-310 Connector Panel
REMOTE PRINTER
/UP-897MD
~ AC IN PRINTER AC outlet

Mounting of Covers

3.

In the case which installed the B/W printer, be careful not to forget installing of the covers.
In the case you want operating the panel moving, operate panel previously with reference to
3.Operating of panel moving.

Install the covers with the reversed procedure of 2-1.Removing of Covers.

Be careful not to pinch the cables, when install the shield cover.

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3. Operating of Panel moving

3.
(up-and-down)

Removing of Covers

In the case which not installed the B/W printer, remove the covers with reference to
procedure (1) and (2) of 2-1.Removing of Covers.

Operating of Panel moving (up-and-down)

Elevator Arm 3

Unfasten 3 hexagonal cap screws to loosen

the arm fixture by accesory wrench.

HB6×20 SUS, 3
SW6 SUS, 3

Arm Fixture

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Monitor Arm

Panel Handle

Mark

Lift the arm up by holding the panel handle

and the bottom of the monitor arm to adjust
the height of the operation panel.

Service personnel must only be

Standing Position allowed to do the adjustment.
Lowest
Do the adjustment from the side of the
machine where the arrow indicates.

The ratchet becomes off when the arm

reached to the upper limit mark and then, it
goes down to the bottom.
At this point, keep hold the arm and do not
drop it. It could cause an injury and/or
damage the machine since it is heavy.

Mark

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Mounting of Covers

In the case which operated of panel moving, be careful not to forget installing of the covers.

Install the covers with the reversed procedure of 2-1.Removing of Covers.

Be careful not to pinch the cables, when install the shield cover.

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4. 4. Installation of Probe Holder

Installation of Probe Holder

HB4×8 SUS, 2
( 3mm)
(Hexagonal wrench Size 3mm) 2 -1
BNK4×10 Fe-Ni, 2

2 -2

Install the probe holder -1 with 2 accessory

screws.

Install the probe holder -2 with 2 accessory

screws. (Accessory hexagon wrench use)

-2 -1
Probe holder-2 Probe holder-1

Layout figure

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5. 5. Installation of Cable Hook

Installation of Cable Hook

Insert and install the cable hook.

Cable hook

Use example

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6. 6. Operating of Caster-lock

Operating of Caster-lock

Step on this side of the pedal and lock the caster.

Pedal

Caster
Lock state

Step on far side of the pedal and release the

lock.

Pedal

Caster

Lock release state

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7. Operating of Monitor moving and

7.
Arm moving

Operating of Monitor moving (up-and-down)

Raise the monitor, and adjust it at desired height.

Monitor

Operating of Monitor moving (tilt)

30° 10°

Tilt the monitor, and adjust it at desired angle.

Monitor (The tilt angle: up: 30°,down: 10°)

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Operating of Arm moving (turn)

Arm

Turning the arm, and adjust it at desired angle.

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Chapter 4 SYSTEM OVERVIEW

4-1 Specification of System

- INDEX -

Summary

1.1 Scanning System

1.2 Operating Modes
1.3 Diagnostic Fields
1.4 Application to patients
1.5 Operators
1.6 Installers
1.7 M -Mode Display
1.8 Depth range selections
1.9 Image Display Mode

Probes

2.1 Number of connectable probes

2.2 Probe Frequency
2.3 Transmission Frequency
2.4 Probe Connect
2.5 Simultaneously Attached Probes
2.6 Switchable Probe System

Transmitting and Receiving part

3.1 Number of elements

3.2 Maximum driving elements
3.3 Transmission Method
3.4 Focusing System
3.5 Receiving Addition System
3.6 Receiving Variable Band Filter
3.7 Transmission Power Control
3.8 Image Controls
3.9 Scanning Line Density
3.10 Transmission Voltage Monitoring
3.11 Number of multiple pulse transmission
3.12 Transmission Power

Digital Scan Converter part

4.1 Image Gradation

4.2 Displayable Scanning Lines
4.3 Scanning Angle
4.4 Image Memory
4.5 Image Display Synchronization Method
4.6 Image Processing
4.7 Cine Memory
4.8 Image Display Functions
4.9 Write in Display Memory

Main Panel Unit

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Chapter 4 SYSTEM OVERVIEW

- INDEX -

Information Displayed

6.1 Automatic Display

6.2 Character Input
6.3 Graphic Displays

Measurement

7.1 Basic measurements

7.2 Obstetrical measurement
7.3 Gynecological measurement
7.4 Cardiac analysis
7.5 Urology measurement
7.6 Peripheral vessels analysis
7.7 Hip Joint Angle

Display Monitor

Image recording devices

9.1 B/W Video Printer

9.2 USB Memory

External Interface

10.1 RS-232C
10.2 USB
10.3 NETWORK
10.4 Video Output Signals
10.5 Control Signals for Video Printer

Electrical Characteristics

Cabinet

12.1 Dimensions
12.2 Weight

Performance

13.1 Penetration
13.2 Resolution
13.3 Ultrasound Frequency
13.4 Maximum Acoustic Output
13.5 Accuracy of Display

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- INDEX -

Device Configuration

14.1 Software Version

14.2 Standard Configuration
14.3 Peripheral equipment
14.4 Probes
14.5 Optional probe’s accessories

Operating Conditions

15.1 Temperature
15.2 Humidity
15.3 Atmospheric Pressure

Classification of Equipment

16.1 Classification according to protection against surges

16.2 Classification according to degree of protection against surges
16.3 Degree of protection against water
16.4 Degree of safety of application in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide
16.5 Mode of operation
16.6 Defibrillation‘s degree of protection against electric shock
16.7 Storage and Transport environment

Applicable Standards

17.1 General Standard

17.2 Standard for EMC
17.3 The others standard rule

Acquiring Attestation

A safety measure about the

Ultrasound Output

A safety measure about measuring

Maintenance and Inspection

21.1 Inspection items before use

21.2 Periodical Safety Tests
21.3 Data Save Function

Appearance and Dimension

22.1 External appearance

22.2 Panel layout

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Chapter 4 SYSTEM OVERVIEW

- Specification -

1 Summary

1.1 Scanning Method

Electronic Linear
Electronic Convex

1.2 Operating Modes

B, B|B, B|M, M

1.3 Diagnostic Fields

Abdominal, Obstetrics, Gynecology
Cardiac, Urinary organ
Peripheral Vessel, Mammary gland
Thyroid gland

1.4 Application to patients

Trans-abdominal, Trans-thorarial,
Inter-corporeal and Intraoperative
However, the direct application to the heart and the central circulatory system is prohibition.

1.5 Operators
Medical Doctor, Sonographer
Radiologist

1.6 Installers
Service personnel

1.7 M -Mode Display

Display method
Scrolling, Moving Bar
Sweep Speed
M-mode 1, 1.5, 2, 3, 4, 6, 8 Sec/Plane

1.8 Depth range selections

3 ~ 21 cm
(Probe dependent)

1.9 Image Display Mode

B , 2B , Zoom , B/M , M

Electronic Electronic
Linear Convex

-Zoom

Available
Conditionally available

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2 Probes

2.1 Number of connectable probes

Electronic linear/convex probe
18probes

2.2 Probe Frequency

1.8 ~ 13MHz.
Probe dependent

2.3 Transmission Frequency

2.14, 2.5, 3.0,
3.75, 5.0, 6.0, 7.5, 10.0 MHz
Probe dependent

2.4 Probe Connect

96 pin DL Connect

2.5 Simultaneously Attached Probes

Max. 2 probes

2.6 Switchable Probe System

3 Transmitting and Receiving part

3.1 Number of elements

80 elements max.

3.2 Maximum driving elements

32 elements

3.3 Transmission Method

Single pulse, Multiple pulse and Burst

3.4 Focusing System

Transmission
Max. 4 Levels + Acoustic lens
(Selectable from 8 kinds)
Reception
Continuously variable + Acoustic lens

3.5 Receiving Addition System

Digital and Analog Summation Method
Electronic probe

3.6 Receiving Variable Band Filter

Compatible with each frequency

3.7 Transmission Power Control

Up/down control with panel switch

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3.8 Image Controls

3.8.1 B Gain
30 ~ 90 dB

3.8.2 M Gain
B-gain ± 30 dB

3.8.3 STC Sensitivity time Control

8 slide controls

3.8.4 Contrast
16 steps

3.8.5 AGC
8 steps

3.8.6 FTC
ON/OFF control

3.8.7 Relief
4 selections OFF 3 levels

3.8.8 Image Frequency Select

4 selections
(Resolution, STD1, STD2, Penetration)

3.9 Scanning Line Density

Variable in accordance with the diagnostic distance zooms and line density settings.

3.10 Transmission Voltage Monitoring

The transmission voltage value is monitoring by CPU, which also stops transmission and cuts off
transmission power supply output.

3.11 Number of multiple pulse transmission

Max. 15 pulses

3.12 Transmission Power

Max +80V, -80 V

4 Digital Scan Converter

4.1 Image Gradation

B/W 8bit, 256 steps

4.2 Displayable Scanning Lines

1024 lines max.
Frame Correlation off

4.3 Scanning Angle

Max. 96 degree(V1.0.0)
Max. 136 degree(V1.1.0)

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4.4 Image Memory

4.4.1 Display Memory
B/W 512×512 8 bit×4

4.4.2 Cine Memory

B/W 65536×512×8 bit

4.5 Image Display Synchronization Method

Ultrasound frame sync
Alternated Image display ON/OFF,

4.6 Image Processing

4.6.1 Line Correlation
3 levels (Off, Low, High)

4.6.2 Frame Correlation

B/W 16 steps each

4.6.3 Frame Interpolation

ON/OFF
Frame Rate Accelerator

4.6.4 Enhancement
5 kinds

4.6.5 View Gamma

5 kinds

4.7 Cine memory

4.7.1 Search Memory
Max.65536 US lines

4.7.2 Scroll Memory

Max.2048 US lines

4.7.3 Store Memory

Review Max. 999 frames

4.8 Image Display Functions

4.8.1 Image location of Left-Right Display

4.8.2 Pan Zoom for B-Mode image

Read Zoom(During Freeze×2 only)
and Write Zoom

4.8.3 Position Movement for B-Mode Image

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4.8.4 Image orientation of B/* Mode

Left-Right Inversion
4.8.5 90 degrees Rotation Display for B-Mode Image

4.8.6 Display Priority Function

4.9 Write in Display Memory

Vector table writing System

Main Panel unit

Track ball
Full key-board
Illuminated switch method by two colors

Information Displayed

6.1 Automatic Display

Date and time
Imaging frequency display
Image direction mark
Display depth range
Gain setting
Contrast ( dB )
Frame rate
Acoustic power output level( MI,TI )
DVA in
Focus mark
BSA/GW/PSA
Preset Name

6.2 Character Input

Hospital name
Patient ID number
Patient name
Patient age, sex, height and weight, body surface area, Gestational week Comment
Movable using a trackball
Annotation character
Movable using a trackball

6.3 Graphic Displays

Display scale
Time mark
Puncture guide line
with depth indication)
Body mark user establish available
M-mode cursor

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Measurement

7.1 Basic measurement

7.1.1 B-Mode measurements
Distance
Area-Trace
Area-Ellipse
Volume
Volume Biplane
Volume Slice
Angle
Hist Box
Hist Trace
%STENO DIST
%STENO Area-T
Ratio DIST
Ratio Area-T
Ratio Ellipse

7.1.2 M-Mode measurements

M.Length
M.Tim
Heart Rate
M.Velocity
%STENO Length

7.2 Obstetrical measurement

7.2.1 For B-mode measurement
1) GA
EES Mean GS GS CRT BPD BPDo
OFD OFDo HC HC2 APTD
APD TTD TAD TL AXT AC FTA
TC FL FIB HL LV TIB ULNA
RAD BD CD LVW HW OOD
IOD User GAdefinition
2) FW
Tokyo BPD APTD TTD FL
Osaka BPD FTA FL
Hadlock1 AC FL
Hadlock2 AC HC FL
Hadlock3 BPD AC FL
Hadlock4 HC AC
Hadlock5 BPD HC AC FL
Shepard BPD AC FL
Shinozuka BPD AC FL
Hansmann BPD TTD
Warsof BPD AC
Campbell AC
JSUM'03 BPD AC FL
User definition
3) Ratio
BPDo OFDo Hadlock
HCA CC Campbell

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FL BPD Hohler
FL AC Hadlock
LVW HW P J
FL HC Hadlock
4) Amniotic fluid measurement
AFI
AF Pocket AFV

7.2.2 For M-mode measurement

Fetus Heart Rate
Fetus Heart Rate before Biopsy
Fetus Heart Rate after Biopsy

7.2.3 Others
1) Data Utilize function
Transfer function of basic measurement value
Transfer function from Report
2) Growth Analysis Graphs
GA Graph
FW Graph
Ratio Graph
AFI Graph
Trend Graph
3) Report
Singleton
Twins
Triplets

7.3 Gynecological measurements

7.3.1 Gynecological measurements
Uterus
Endmetrial Thickness
Cervix
Rt/Lt Ovary
Follicles(Distance)
Follicles(2Caliper)
Follicles(Cross Caliper)

7.3.2 Others
1) Report
Uterus
Cervix
Ovary Follicles Diameter

7.4 Cardiac analysis

7.4.1 B mode
1) Left ventricle analysis
Pombo
Pombo wall
Teichholz
Teichholz wall
Gibson
Gibson wall

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2) Others
Pombo
S.Plane Ellipse
Biplane Ellipse
Bullet
Modified Simpson
Simpson
LAX
LAX(Wall)
SAX
APX

7.4.2 M mode
1) Left ventricle analysis
Pombo
Pombo wall
Teichholz
Teichholz wall
Gibson
Gibson wall
2) Various valve measurements
Mitral Valve
Aortic Valve
Tricuspid Valve
Pulmonary Valve

7.4.3 Others
1) Report
LV Function
LV Measured Data
M-mode Valve Function

7.5 Urology measurement

7.5.1 Urology measurement
PSA Volume
Seminal Vesicles
Bladder Volume
Testis Volume
Renal Volume
Cortical Thickness
Adrena

7.5.2 Others
1) Report
Prostate
Seminal Vesicles
Bladder
Testis
Renal
Surgery

7.6 Peripheral vessels analysis

7.7 Hip Joint Angle

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8 Display Monitor

12.1inch LCD
VGA 640 480

9 Image recording devices

9.1 B/W Video Printer

9.2 USB Memory

10 External Interface

10.1 RS-232C

10.2 USB
USB 1.1 TypeA

10.3 Network
10/100BaseTX RJ-45 System

10.4 Video Output Signal

B/W composite 1 System

10.5 Control Signals for B/W Video Printer

B/W composite 1 System
PRINT/BUSY System

11. Electrical Characteristics

Voltage AC 100 ~ 120V ± 10%

AC 200 ~ 240V ± 10%
Power Consumption
Less than 150 VA
Frequency 50/60Hz

(250VA)

12 Cabinet

12.1 Dimensions
Width 420 mm
Height 1209 1509mm
Depth 616mm

12.2 Weight
Max. 65 kg Main unit only

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13 Performance
Perform the following checks for the Probes listed at item 14.4

13.1 Penetration
The probe is applied on top of ultrasonic phantom (RMI 403GS), reflection echo of the nylon line
of 2cm interval looks over is inspected. The depth where you can use ultrasonic phantom
RMI403GS, you cannot distinguish with electric noise speckle pattern due to JIS T1501 2005 5.2a)
and becomes is above 70mm(B mode).(70mm: B mode damping coefficient the converted score
to 0.3dB/cm MHz)

13.2 Resolution
The minimum distance that can b e recognized in water is measured by watching by using test target
KG-037-ASU-35 or equal goods. To obtain the highest resolution, the test target adjusts and
arranges the distance with the probe.

Resolution by JIS T 1501 2005 5.2 b) 1), 2) must be below the following. The minimum interval
made an image must be 2mm or less in a plain axial resolution. The azimuth resolution must be
3mm or less.

13.3 Ultrasound frequency

When you used the oscilloscope, period T1 of the echo ripple mark from the underwater reflector
and T2 ( s) you measured due to zero cross methods and calculating ultraaudible frequency with
the next formula, it is within the ±20% of ultraaudible frequency of the probe. However T1 and T2
make 2 period which includes the largest amplitude of echo and half period shifting, set T2,
vis-à-vis T1.

Furthermore, it rounds the 2nd beam below the decimal point and displays at the MHz unit.

JIS T 1501:2005 5.2 d) it depends on the section, acoustic operation frequency is within the ±20%
of ultraaudible frequency of the probe.

13.4 Maximum Acoustic output

Attenuated spatial-peak temporal- average intensity and a mechanical index by JIS T 0601-2
-37:2005 must be below the following. Attenuated spatial-peak temporal- average intensity:
Izpta,3 : 720mW/cm2
Mechanical index
MI : 1.9

13.5 Accuracy of display

The nylon string circle target or equal goods must be used, and the echo in the water of 40 5
must be within 5% when you request the error margin of the display accuracy by using the
distance measurement with the caliper.

14 Device configuration

14.1 Software Version

Ver. 1.0.0

14.2 Standard configuration

14.2.1 Diagnostic equipment part
Ultrasound Equipment
SSD-Prosound4 1 System
Class a MDD Annex , Rule 10

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1) Diagnostic equipment proper

USI-159

2) Main Panel 1
PNL-PROSOUND4

14.2.2 Accessories

1) Video printer control cable

AUW1-150

2) Power supply code

CP-117

14.2.3 Documents
1) Instruction manual
MN1-5553 Users Guide
MN1-5554 Measurement
MN1-5555 Power Data Book

2) Installation manual

3) Test Certificate
F-QQ-25

14.3 Peripheral equipment

14.3.1 Recording equipment
1) B/W video printer 1

14.3.2 Other Equipment

1) Foot switch
Foot switch MP-2345B 1System
Triple foot switch MP-2614B 1System
14.4 Probes
14.4.1 Electronic convex probe
1) UST-9137 For Abdominal, OB/GYN
50R, 62°
Class a MDD Annex , Rule 10

2) UST-934N-3.5
For Abdominal, OB/GYN
60R, 68°
Class a MDD Annex , Rule 10

3) UST-935N-5
For Abdominal, OB/GYN
60R, 57°
Class a MDD Annex , Rule 10

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4) UST-944B-3.5
For Cardiac Abdominal
20R, 96°
Class a MDD Annex , Rule 10

5) UST-974-5 For Neonatal Cephalic

20R, 55.5°
Class a MDD Annex , Rule 10

14.4.2 Transvaginal electronic convex probe

1) UST-945B-5 For OB/GYN
20R,55.5°
Class a MDD Annex , Rule 5

2) UST-981-5 For OB/GYN

14R, 96°
Class a MDD Annex , Rule 5

14.4.3 Intraoperative electronic convex probe

1) UST-9111-5 For Neonatal Cephalic
14R, 96°
Class a MDD Annex , Rule 6

14.4.4 Electronic linear probe

1) UST-5551 For Peripheral Vessels
40mm
Class a MDD Annex , Rule 10

2) UST-5512U-7.5
For Peripheral Vessels
43mm
Class a MDD Annex , Rule 10

3) UST-5711-7.5
For Peripheral Vessels
57mm
Class a MDD Annex , Rule 10

4) UST-586-5 For Abdominal

72mm
Class a MDD Annex , Rule 10

14.4.5 Intraoperative electronic linear probe

1) UST-556I-5 For Intraoperative
43mm
Class a MDD Annex , Rule 6

2) UST-556T-5 For Intraoperative

43mm
Class a MDD Annex , Rule 6

3) UST-556TU-5 For Intraoperative

43mm
Class a MDD Annex , Rule 6

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4) UST-5820 For Intraoperative

72mm
Class a MDD Annex , Rule 6

5) UST-587I-5 For Intraoperative

72mm
Class a MDD Annex , Rule 6

14.4.6 Transrectal probe

1) UST-660-7.5 For Prostate
72mm
Class a MDD Annex , Rule 5

14.5 Optional probe’s accessories

14.5.1 Puncture Adapter
1) MP-2387
For UST-556T-5

2) MP-2392
For UST-556TU-7.5

3) MP-2408B
For UST-934N-3.5

4) MP-2414C
For 944B-3.5

5) MP-2420B
For UST-935N-5

6) MP-2445(-SET)
For UST-945B-5 UST-981-5

7) MP-2456
For UST-5710-7.5

8) MP-2366
For UST-660-7.5

9) CIV-614-091
UST-5551

10) MP-2467
For UST-974-5

14.5.2 Water Path

MP-2463
For UST-5711-7.5

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15 Operating conditions

15.1 Temperature
+10 ~ 40

15.2 Humidity
30 ~ 75

15.3 Atmospheric pressure

700 ~ 1060 hPa

16 Classification of Equipment

16.1 Classification according to protection

against surges
Class I equipment

16.2 Classification according to degree of

protection against surges
Type BF applied part only

16.3 Degree of protection against water

Ordinary equipment

16.4 Degree of safety of application in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide

Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide

16.5 Mode of operation

Continuous operation

16.6 Defibrillation‘s degree of protection against electric shock

Arrangements not used to isolate defibrillation-proof applied parts

16.7 Storage and Transport environment

1) Temperature -10 ~ 50
2) Humidity 10 ~ 90 %
3) Atmospheric pressure 700 ~ 1060 hPa

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17 Applicable Standards
Perform the following checks for the optional Probes listed at section 14.4

17.1 Standard for safety

1) Medical electrical equipment Part1 General requirement for safety-
IEC60601-1 Ed2(1988)+Am1(1991)
+Am2(1995)

2) Medical electrical equipment Part 2-37

Particular requirements for safety of ultrasonic medical diagnostic and monitoring equipments
IEC 60601-2-37, 2001
Am1:2004 Am2:2005

17.2 Standard for EMC

1) Medical electrical equipment Part1
General requirements for safety-Collateral standard
Electromagnetic compatibility-
Requirement and tests
IEC60601-1-2, Ed2.1 2005

2) Industrial, scientific and medical(ISM) radio-frequency equipment - Electromagnetic disturbance

characteristics – Limits and methods of measurement
CISPR 11 Ed.4.1:2004 +Am.2:2006
(Group 1 Class B)

3) Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic

current emissions (equipment input current <= 16A per phase)
IEC 61000-3-2 Ed.3.0:2005

4) Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage supply systems, for equipment with rated
current <= 16 A per phase and not subject to conditional connection
IEC 61000-3-3 Ed.1.2:2005

5) Electromagnetic compatibility (EMC)- Part 4-2: Testing and measurement

techniques - Electrostatic discharge immunity test
IEC 61000-4-2 Ed.1.2:2001

6) Electromagnetic compatibility (EMC)

- Part 4-3: Testing and measurement techniques - Radiated,
radio-frequency, electromagnetic field immunity test
IEC 61000-4-3 Ed.3.0:2006

7) Electromagnetic compatibility (EMC)

- Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
IEC 61000-4-4 Ed.2.0:2004

8) Electromagnetic compatibility (EMC)

- Part 4-5: Testing and measurement techniques - Surge immunity test
IEC 61000-4-5 Ed.2.0:2005

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9) Electromagnetic compatibility (EMC)

- Part 4-6: Testing and measurement techniques - Immunity to conducted
disturbances, induced by radio-frequency fields
IEC 61000-4-6 Ed.2.1:2004
+ Am.2:2006

10) Electromagnetic compatibility (EMC)

- Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
IEC 61000-4-8 Ed.1.1:2001

11) Electromagnetic compatibility (EMC)

- Part 4-11: Testing and measurement techniques - Voltage dips, short
interruptions and voltage variations immunity tests and voltage variations
on power supply input lines
IEC 61000-4-11 Ed.2.0:2004

17.3 The others standard rule

1) Maximum acoustic power
FDA510(k) Track3
2) Distance measurement accuracy
JIS T 1501:2005
3) Design life 7years
4) Medical electrical equipment
General requirement for safety-
JIS T 0601-1:1999
5) Electromagnetic compatibility
JIS T 0601-1-2:2002
6) EN980:2003

17.4 EC Instruction
EC instruction MDD(93/42/EEC) Annex I

17.5 Usability
IEC-60601-6 2004

18 Acquiring attestation

18.1 Necessary attestation for manufacturing and sales for Japan and overseas
18.1.1 Authorization and/or approval under
medicines act for manufacturing.
Medical device export application

18.1.2 Attestation for sales in EC

Medical equipment production approval Self-approval files on EC act MDD(93/42/EEC)
Display language based on each countries Requirement

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18.1.3 Attestation for sales in courtiers other than

Japan, EC and Japan
Medical equipment production approval
CB certificate

19 A safety measure about the

Ultrasound Output

Explanation about a setup of the sound power of every application by the instruction manual

Sound power relative indication Function

(Voltage value standard DVA display)

Acoustic power establishment function by the application

An automatic escape function from acoustic power establishment function

Mechanical index, Thermal index indication function

A transmitting stop function by the CPU running recklessly detection Hardware

The transmission voltage value is monitoring by CPU, which also stops transmission and cuts off
transmission power supply output

20 A safety measure about measuring

Indicating clearly of a precision limit, measurement purpose and process

The reliability of the user table data

Securing function

The regular inspection of the indication precision

Before using date time by the user, check

Before using a connector by the user, check

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21 Maintenance and Inspection

21.1 Inspection items before use

21.1.1 Damage of surface on equipment

21.1.2 Damage of plug and cable for power unit

21.1.3 Damage of outside and cable of probes

21.1.4 Operation check with probes

21.1.5 Check of date and time Displayed on monitor

21.2 Periodical safety tests

21.2.1 Items to be inspected weekly

Fixing condition of the following parts
Monitor and monitor arm,
Fixtures for optional devices, optional device

21.2.2 Items to be inspected monthly

Fixing condition of casters

21.2.3 Items to be inspected yearly

Earth leakage current
Enclosure leakage current
Patient leakage current
Protective earth resistance
Accuracy of display

21.3 Data Save function

Securing reliability of the backup data

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22 Application and Dimension

22.1 External appearance

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22.2 Panel layout

Prosound4 have three different points between Prosound6 operation panel.

No external switch
No Mechanical probe select switch
No AIP switch

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4-2 System configuration

This ultra sound diagnostic system (Prosound 4) is comprised of the following units.
4-2-1 EXPORT-PAL

scamatic

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scamatic

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scamatic

Mitsubishi f

Mitsubishi

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