EU-M30 ENDOSCOPIC ULTRASOUND CENTER Instructions June 2000

2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (0426)46-2429 Telephone: (0426)42-2111

(Premises/Goods delivery) Wendenstrasse 14-16, D-20097 Hamburg, Germany (Letters) Postfach 10 49 08, D-20034 Hamburg, Germany Telephone: (040)237730

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KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom Telex: 995283 Fax: (01702)465677 Telephone: (01702)616333

491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: 834-2438 Telephone: 834-0010

Rm. 818, South Tower, Beijing Kerry Centre, No.1 Guanghua Road, Chaoyang District, Beijing, 100020, China Fax: (10)8529-8085 Telephone: (10)8529-8080

117071, Moscow, Malaya Kaluzhskaya 19, bld. 1, fl.2, Russia Fax: (095)958-2277 Telephone: (095)958-2245

1/104 Ferntree Gully Road, Oakleigh, VIC 3166, Australia Fax: (03)9543-1350 Telephone: (03)9265-5400

Style 10

GC3263 05

Printed in Japan 20000626 :0000

CONTENTS PART 1 1

Introduction Safety

1--1

1.1 1.2 1.3 1.4 1.5 1.6 1.7

1--1 1--1 1--1 1--1 1--1 1--1 1--2

Intended Use... Instruction Manual... Instrument Compatibility... Upon Receipt... Repair / Modification... Signal Words... Warnings and Cautions...

2

Standard Set

2--1

3

Nomenclature and Functions

3--1

3.1 3.2 3.3

3--1 3--4 3--6

4

5

PART 2 6

Specifications

4--1

4.1 4.2 4.3

4--1 4--1 4--2

8

Installation... Regulatory Classification... EU--M30 Operation...

General Precautions

5--1

Usage for stand alone ultrasonic system Preparation

6--1

6.1 6.2

6--1

6.3 6.4

7

Nomenclature... Optional Parts... Construction...

Installation of EU--M30... Connection of the cables between the EU--M30 and ancillary equipment... Power Connections of EU--M30... Connection of ultrasonic endoscope or Probe Driving Unit...

6--3 6--8 6--9

Inspection

7--1

7.1 7.2 7.3 7.4

7--1 7--2 7--3 7--4

Power Supply... Inspection if power fails to come ON... Ultrasonic image on display monitor... Adjusting the Monitor...

Operation 8.1 8.2 8.3 8.4

8--1

Entering data... 8--1 Adjusting Ultrasonic Image... 8--5 Recording and playback... 8--13 Measurement Functions... 8--16

9

10

Maintenance and Storage

9--1

9.1 9.2

9--1 9--1

Maintenance... Storage...

Troubleshooting and Service 10.1 10.2

Troubleshooting... 10--1 Service... 10--2

PART 3

Usage for the system combined with EVIS

11

Specification for use combined with CV--100/CV--200/CV--140 11.1 11.2

12

12.3 12.4 12.5

11--1

Selection of the Ultrasound image... 11--2 Selection of the EVIS image... 11--3

12--1

Preparation 12.1 12.2

10--1

Installation of EU--M30... 12--1 Connection of the cables between EU--M30, CV--100/CV--200/CV--140 and ancillary equipment... 12--4 Installation of Track Ball MH--869 (Optional) onto the Compact Video Trolley TC--V1... 12--14 Installation of Track Ball MH--869 (Optional) onto the Mobile Workstation WM--30... 12--16 Power Connections of EU--M30 and CV--100/CV--200/CV--140 . . 12--17

13

Inspection

13--1

14

Operation

14--1

14.1 14.2 14.3 14.4

15

Power Supply to the system... 14--1 Additional Keyboard functions... 14--1 Recording the EVIS Image on the Video Printer... 14--3 Recording and playback of EVIS Image on the VTR... 14--5

Troubleshooting and Service 15.1 15.2

15--1

Troubleshooting... 15--1 Service... 15--1

APPENDIX

A

System Chart

APPENDIX

B

Acoustic Output Table

PART 1 Introduction

1--1

1--1

1 SAFETY 1.1 Intended Use This instrument has been designed to be used with the Olympus ultrasonic endoscopes, Olympus ultrasonic probes or Olympus esophageal ultrasonic probe to observe real--time, ultrasonic images. Only trained medical personnel should use this instrument. Do not use for any purpose other than its intended use. The EU--M30 may be built into two types of systems. One is the stand alone ultrasonic system. The other is the ultrasonic system combined with the EVIS Video System Center.

1.2 Instruction Manual Before use, thoroughly review this manual and the manuals of all instruments which will be used during the procedure. The endoscopic technique and medical aspects of endoscopy are not discussed in this manual. Keep all instruction manuals in a safe, accessible location. If you have any questions and comments concerning information in this manual, please contact Olympus. Refer to PART 2 for instructions on using the ultrasound centre as a stand alone system. Refer to PART 3 for instructions on the combined use of the ultrasound centre with an EVIS Video System Center.

1.3 Instrument Compatibility Refer to the system chart in Appendix A to confirm that the EU--M30 is compatible with the ancillary equipment being used. Using incompatible instruments or equipment can result in patient injury or equipment damage.

1.4 Upon Receipt Visually inspect the instrument for damage and confirm that it operates correctly. Do not use this instrument if it appears to be damaged; contact Olympus.

1.5 Repair / Modification This instrument contains no user serviceable parts. Do not modify or attempt repair; patient injury or equipment damage can result.

1.6 Signal Words The following words are used throughout this manual. DANGER

:

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

1--2

1--2

WARNING

:

CAUTION

:

NOTE

:

Indicates a potentially hazardous situation which, if not avoided, may result in moderate or minor injury. Indicates a potentially hazardous situation which, if not avoided, may result in equipment damage. Indicates additional, helpful information.

1.7 Warnings and Cautions WARNING

S

S S

The EU--M30 is not explosion--proof. Do not operate the EU--M30 where flammable anesthetics are used or in a room recently washed with flammable cleaning and disinfecting agents. Cleaners can produce explosive vapors. The EU--M30 is type BF electro--medical equipment. Leakage current from Type BF equipment may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points. Never apply a connected ultrasonic endoscope or probe to the heart. Never allow an accessory, another endoscope, etc. which is in contact with the heart (or heart region) to come into contact with the ultrasonic endoscope or probe, when connected to the EU--M30.

S

Observe the following precautions strictly. Failure may place the patient and medical personnel at risk of electrical shock. Never use the EU--M30 in conjunction with electro--surgical equipment. Keep liquids away from the EU--M30. If spilled liquid has entered the EU--M30, stop the operation immediately and contact Olympus. Do not prepare, inspect or use EU--M30 with wet hands. Always connect all ancillary equipment to an AC mains socket via isolation transformer.

S S CAUTION

S S S S S

To prevent electrical shock hazards, the main frame of the EU--M30 must be grounded securely and effectively. Always connect the 3--pin power cord plug to an output socket. Do not use the EU--M30 in environment where electrical noise is generated by electro--surgical equipment, etc. When using ultrasonic endoscope or probe in conjunction with X--ray device, electrical noise may appear in the ultrasound image. To prevent equipment damage, never touch the electrical contacts on the scope connector. Do not place objects on or near the ventilation grills of the equipment in use. When used in conjunction with any other electrical device always ensure they have undergone a full safety check.

2--1

2--1

2 STANDARD SET Please check each item in the set against the standard set below. If anything is missing or you have any questions, contact Olympus immediately.

Description

Quantity

1. Endoscopic Ultrasound Center EU--M30...

1

2. Power cord...

1

3. Keyboard (with function template)...

1

4. Foot Switch...

1

5. BNC Cable MB--672...

1

6. Remote Cable MH--907...

1

7. Foot Holder MD--512... 1 (4 pieces) 8. Instruction Manual...

3. Keyboard 1. EU--M30 2. Power Cord

4. Foot Switch

6. Remote Cable

5. BNC Cable

7. Foot Holder

1

3--1

3--1

3 NOMENCLATURE AND FUNCTIONS 3.1 Nomenclature MAIN FRAME ( Front Panel )

Scope Socket Electrical connection to the ultrasonic endoscope or probe driving unit Power Switch Illuminates in green colour while the power ON

MAIN FRAME ( Side View )

Ventilation Grill

Grip

3--2

3--2

MAIN FRAME (Rear Panel) NOTE

S

Refer to the section ”6.2 Connection of the cables between the EU--M30 and ancillary equipment”. Monochrome Video Monitor Output Socket Ultrasound signal for the monitor

Monochrome Video Printer Output Socket Endoscopic Image File Device I/O Connectors

Video Monitor Input Socket Inputs the EVIS image from the CV--100/CV--200.

RS--232C Port

Video Monitor Output Socket Outputs the image from EU--M30

Connector for future application

Video Printer for colour Output Connector Connector for the video signal and remote control signals for the VTR

Card Reader Port Connector for card reader or bar code reader Digital Interface Port Digital communication signals to and from future application

Video signal/remote Port Power Circuit Breaker

EU--M30 keyboard Connector Connector for entering data from keyboard

AC power inlet

EVIS keyboard Connector Connector for keyboard data from the EU--M30 for EVIS video system center Foot Switch Connector Video Printer remote connectors

Input/Output Connectors I/O ports for combined use with EVIS and VTR SFor VHS/Umatic LINE IN : from CV to EU--M30 LINE OUT : from EU--M30 to CV SFor S--VHS Y/C IN : from CV to EU--M30 Y/C OUT : from EU--M30 to CV

3--3

3--3

KEYBOARD NOTE

S

Refer to the section ”8 Operation” for details.

Function Switches

Release Pressed to transfer current screen image to properly integrated optional monochrome video printer. Recording Device Control Pressed to operate the recording devices. Recording Device Selector

Display mode Pressed to select the image display mode.

STC Controller Pressed to change the amplification of the receiving ultrasonic echo at each depth.

Calipers

Contrast Adjusts the image contrast in 8 Pre--determi ned levels.

Gain Adjusts the overall amplification of the receiving ultrasonic echo. Image Direction Pressed to change the viewing direction of scanning cross section (normal/inverse). Image Rotation Pressed to turn ON/OFF the image rotate function. Range selector Pressed to change the image display range.

Touch Screen Slide the finger tip on the panel surface for moving cursor or rotating the image.

Freeze Pressed to change from the FREEZE mode into REAL--TIME mode. Pressed to revert from the REAL--TIME mode into FREEZE mode. Subscreen switch Pressed to display the endoscopic image for subscreen in the ultrasonic image when combined with EVIS. Current Image Selector Pressed to select the displayed image; SCOPE (REAL--TIME mode), VTR, IMAGE FILE. EVIS key is activated when an EVIS system is connected.

3--4

3--4

FOOT SWITCH

Release Pressed to transfer current screen image to properly integrated optional monochrome video printer.

Freeze Pressed to change from the FREEZE mode into REAL--TIME mode. Pressed to revert from the REAL--TIME mode into FREEZE mode.

3.2 Optional Parts 1. Track Ball; for the quick activation of the following functions. a. Image Rotation b. Transfer of caliper mark on the monitor c. Transfer of cursor when entering comments

Connector Connect to the rear panel of main unit.

3--5

3--5

2. EVIS--EUS Connecting Cable A (MH--870); for connecting the EU--M30 to the CV--100/CV--200/CV--140. Refer to PART 3; Usage for the system combined with EVIS.

3. EVIS--EUS Connecting Cable B (MH--878); for connecting the EU--M30 to the CV--100/CV--200/CV--140. Refer to PART 3; Usage for the system combined with EVIS.

3--6

3--6

3.3 Construction The EU--M30 Endoscopic Ultrasound Center is designed to control the scanning of ultrasonic endoscope or endoscopic ultrasonic probe set inserted in the body cavity, to receive reflected echoes from the tissue, and to display the ultrasonic image on the monitor. The reflected ultrasonic echoes will be amplified and stored temporarily at the digital scanning converter. The converted signal is displayed on the monitor.

Endoscopic Ultrasound Center Foot Switch Control Section

Probe Driving Unit

Endoscopic Ultrasonic Probe OR

Isolation Circuit

Keyboard Transmittance Circuit

Amplifier

Ultrasonic Endoscope

Digital Scan Converter

Secondary Circuit

Display Monitor

Isolation Transformer

Applied Part Power Circuit Connector Section

Power Source

4--1

4--1

4 SPECIFICATIONS 4.1 Installation Operating and storage Environment

Power Requirements

Ambient Temperature

10--40_C

Relative Humidity

30--85%

Atmospheric Pressure

700--1060hPa

Electric Supply Voltage Fluctuation Frequency Frequency Fluctuation

230 V

Input Current

0.8A

Dimensions

Main Unit Keyboard Foot Switch

Weight

Main Unit Keyboard Foot Switch

Size

¦10% 50 / 60 Hz ¦3%

530mm(W)¢510mm(D)¢102mm(H) 464mm(W)¢197mm(D)¢ 40mm(H) 220mm(W)¢130mm(D)¢ 35mm(H) :16 (kg) : 3 (kg) :1.2 (kg)

4.2 Regulatory Classification Classification ((Medical Electrical Equipment)

Regulatory Status

Waste Electrical and Electronic Equpiment

Equipment Type

Class I , Type BF, defined in IEC standard 601--1, Safety of Medical Electrical Equipment

Degree of protection against explosion

Never use the EU--M30 where there is a risk of flammable gases.

European Economic Area (EEA)

0197

CE marked in accordance with Directive 93/42/EEC of 14 June 1993 concerning medical devices. Year of manufacture is given in second digit of serial no.

In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately. Refer to your local Olympus distributor for return and/or collection systems available in your country.

4--2

4--2

4.3 EU- M30 Operation

Monitor Observation

Signal Processing

Measurement

Display

Ancillary Equipment

Display Mode

B--Mode

Display Polarity

Positive Display only

Scanning Display

Full Circle, Bottom Sector, Top Sector

Display Range

1 , 2 , 4 , 6 , 9 , 12 cm range

Image Direction

Normal / Inverse

Image Rotation

Rotatable (64 steps)

Usable frequencies

7.5 , 12 , 20 , 30 MHz

Signal Processing Settings

GAIN, STC and CONTRAST settings retained in memory when power is turned ON/OFF.

Gain

16--step adjustable

Contrast

8--step adjustable

STC

Partly amplifies/attenuates sections of the US image by using 7 segments in 7 steps.

Distance

Measures distance defined by the + and ¢ calipers.

Area/Circumference

Measures area/circumference enclosed by caliper tracing.

Calendar Timer

Automatically displays date and time.

Frequency Display

Displays current Frequency

Display Signal Processing Settings

Displays GAIN, CONTRAST

Display Characters

Alphanumerics and Symbols.

Photographic and Recording Units

Video Printer (colour/Monochrome), VTR, Image Filing Device (to be marketed in the future)

Remote Controllers

Foot Switch, Track Ball (Optional), Ultrasonic Endoscope Remote Switches

4--3

4--3

Keyboard

Cleanable flat panel keyboard

Selectable Screen (US/EVIS)

Displays US image or EVIS image selectively. (This function is only available when the EU--M30 is combined with the CV--100/CV--140/CV--200.)

Subscreen Function

Displays the endoscopic image for inset image in the ultrasound image. (This function is only available when the EU--M30 is combined with the CV--100/CV--140/CV--200.)

Others

5--1

5--1

5 GENERAL PRECAUTIONS Observe the following precautions when handling this instrument. WARNING

CAUTION

S

This device is not intended for fetal use.

S

To prevent unnecessary patient exposure to ultrasound radiation, follow the as--low--as--reasonably--achievable (ALARA) principle with Olympus ultrasound equipment. Freeze the image whenever you are not actively viewing the “live” ultrasound image. When the equipment is in the FREEZE mode, no ultrasonic energy is emitted into the patient. During transport, always handle the endoscopic ultrasound center EU--M30 with care. Always be aware of other mechanical hazards when transporting the EU--M30.

S

S

Switches on the keyboard should not be pressed with a pointed or hard object since this will damage the surface of the keyboard.

5--2

5--2

Scope

Symbol and Descriptions

VTR Power Switch

Image File

ON

Recording Device Selector

OFF

VTR SVR

Keyboard Switch Printer Freeze

Memorize And Stack

Release

Printout Image

Current Image Select

Delete All Image Memory

US Image

Real--Time Mode

EVIS Image

Change Activated Memory

Subscreen

Backwards Scrolling

Subscreen Positon

Record

STC

Playback

Contrast

Stop

Gain

Pause

Range Select

Forward

Scanning Display Full Circle Bottom Sector

Backward Others See Instructions For Use

Top Sector Circuit Breaker Image Direction

Type BF Equipment

Image Rotation Potential Equalization Terminal

PART 2 Usage for stand alone ultrasonic system