eu-me2_series_endoscopic_ultrasound_center_instruct.pdf
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INSTRUCTIONS
Labels and Symbols
1
Important Information — Please Read Before
Use
3
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
Summary of Equipment Functions
15
OLYMPUS EU-ME2 PREMIER PLUS
OLYMPUS EU-ME2 PREMIER
OLYMPUS EU-ME2
Chapter 1
Checking the Package Contents
17
Chapter 2
Nomenclature and Functions
19
Chapter 3
Installation and Connection
35
Chapter 4
Function Setup
75
Chapter 5
Inspection
139
Chapter 6
Operation
153
Chapter 7
Functions
177
Chapter 8
Measurement and Analysis
425
Chapter 9
Care, Storage, and Disposal
523
Chapter 10 Troubleshooting
527
Appendix
541
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Contents
Contents
Labels and Symbols .......................................................................................................... 1
Important Information — Please Read Before Use ......................................................... 3
Intended use .......................................................................................................................... 3
Instruction manual ................................................................................................................. 3
User qualifications ................................................................................................................. 8
Instrument compatibility ......................................................................................................... 8
Repair and modification ......................................................................................................... 8
Signal words .......................................................................................................................... 9
Dangers, warnings, and cautions .......................................................................................... 9
Cardiac applications ............................................................................................................ 12
ALARA principle .................................................................................................................. 13
Reference materials ............................................................................................................ 14
Summary of Equipment Functions ................................................................................ 15
Main function of each Ultrasound Center ............................................................................ 15
Difference of function about scanning type of electronic scanning ultrasound endoscope . 16
Chapter 1 Checking the Package Contents ....................................... 17
1.1
Checking the package contents ............................................................................ 17
Chapter 2 Nomenclature and Functions ............................................ 19
2.1
Symbols and descriptions ..................................................................................... 19
2.2
Front panel .............................................................................................................. 22
2.3
Rear panel ............................................................................................................... 24
2.4
Keyboard (MAJ-1995) ............................................................................................. 26
2.5
Rear panel of the keyboard ................................................................................... 32
2.6
Side panels .............................................................................................................. 33
2.7
Touch panel and monitor display ......................................................................... 34
Chapter 3 Installation and Connection ............................................... 35
3.1
Precautions for installation and connection ........................................................ 35
3.2
Installation workflow .............................................................................................. 36
3.3
Installation of the equipment ................................................................................. 37
Installation on the mobile workstation (WM-NP2, WM-DP2, WM-NP1, WM-WP1, WM-DP1) ..
37
3.4
Connection with the monitor ................................................................................. 39
OEV261H ............................................................................................................................ 39
OEV191H ............................................................................................................................ 43
OEV191 ............................................................................................................................... 46
3.5
Keyboard ................................................................................................................. 47
3.6
Foot switch ............................................................................................................. 48
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3.7
Connection of the digital video recorder (DVR) ................................................... 49
IMH-20 ................................................................................................................................. 49
IMH-10 ................................................................................................................................. 51
DVO-1000MD ...................................................................................................................... 52
3.8
Connection with the video printer ......................................................................... 54
OEP-5 .................................................................................................................................. 54
OEP-4 .................................................................................................................................. 56
UP-897MD, P93E ................................................................................................................ 58
3.9
Connection with the video system center ............................................................ 60
CV-190 and CV-290 .............................................................................................................
CV-180 .................................................................................................................................
CV-160 .................................................................................................................................
CV-260SL and CV-260 (HDTV) ...........................................................................................
CV-260 (SDTV) ....................................................................................................................
60
62
64
66
68
3.10 Connection with the filing system ........................................................................ 70
3.11 Connection with the external storage device ...................................................... 70
3.12 Connection with the AC mains power supply ...................................................... 71
Chapter 4 Function Setup .................................................................... 75
4.1
List of setting functions ......................................................................................... 75
Setting types ........................................................................................................................ 75
Setting menus and their outlines ......................................................................................... 76
4.2
Opening/closing the system setup menu ............................................................. 77
4.3
General .................................................................................................................... 80
Patient data .........................................................................................................................
Hospital name ......................................................................................................................
Display format of the date ....................................................................................................
Date .....................................................................................................................................
Time .....................................................................................................................................
4.4
Display ..................................................................................................................... 84
Scale bar .............................................................................................................................
Clear comment (freeze off) ..................................................................................................
Clear measurement (freeze off) ...........................................................................................
Select Thermal Index ...........................................................................................................
Frequency band ...................................................................................................................
PinP .....................................................................................................................................
EVIS/US ..............................................................................................................................
Pressurization state guide ...................................................................................................
Comparison indication of strain ratio ROI ............................................................................
4.5
81
81
81
82
83
85
86
86
86
87
87
88
88
89
Video signal ............................................................................................................. 90
Video signal format .............................................................................................................. 91
HD aspect ratio .................................................................................................................... 92
4.6
Function 1 ............................................................................................................... 93
CUSTOM key ...................................................................................................................... 94
ENHANCE setting ............................................................................................................... 96
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Scope switches .................................................................................................................... 96
4.7
Image parameter setup (electronic scanning) ..................................................... 97
Image settings of B mode .................................................................................................... 98
Image settings of PW mode .............................................................................................. 100
Image settings of CH-EUS mode ...................................................................................... 101
4.8
Function 2 ............................................................................................................. 102
Setting items of each tabs ................................................................................................. 104
Setting items of each tabs (SAVE/REC key setting) .......................................................... 104
4.9
Save ....................................................................................................................... 105
Release time ...................................................................................................................... 105
Still image format (for save) ............................................................................................... 106
4.10 Remote .................................................................................................................. 106
Remote .............................................................................................................................. 108
DVR ................................................................................................................................... 108
Monitor and keyboard setting (CV combination) ............................................................... 109
4.11 Comment ............................................................................................................... 109
4.12 Security setup ....................................................................................................... 111
Outline of security setup ..................................................................................................... 111
Security setup flow ............................................................................................................. 112
Security ............................................................................................................................... 113
Security account ................................................................................................................. 115
Administrator ...................................................................................................................... 118
Database user .................................................................................................................... 119
Password setting of the user ............................................................................................. 121
4.13 System reset ......................................................................................................... 122
4.14 Reset menu ........................................................................................................... 125
Reset the image adjustment settings ................................................................................ 126
Reset all settings ............................................................................................................... 126
4.15 Summary of system setup ................................................................................... 127
4.16 Setting the keyboard ............................................................................................ 135
Setting the DIP switches .................................................................................................... 136
4.17 Setting the video system center ......................................................................... 137
CV-260, CV-260SL ............................................................................................................ 137
CV-190, CV-290 ................................................................................................................. 137
Chapter 5 Inspection .......................................................................... 139
5.1
Precautions for inspection .................................................................................. 139
5.2
Inspection workflow ............................................................................................. 140
5.3
Inspection of the power supply .......................................................................... 141
5.4
Inspection of the monitor display ....................................................................... 142
5.5
Adjustment of the monitor .................................................................................. 143
5.6
Inspection of the ultrasound image display ...................................................... 143
Inspection of the B mode image ........................................................................................ 143
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Inspection of the FLOW mode image ................................................................................
Inspection of the PW mode image .....................................................................................
Inspection of the CH-EUS mode image .............................................................................
Inspection of the ELST mode image .................................................................................
145
148
149
150
5.7
Inspection of the video system center ............................................................... 151
5.8
Power OFF ............................................................................................................. 152
Chapter 6 Operation ........................................................................... 153
6.1
Precautions for operation .................................................................................... 153
6.2
Operation workflow .............................................................................................. 155
6.3
Connecting the ultrasound endoscope or probe driving unit .......................... 156
Ultrasound endoscope ....................................................................................................... 157
RS adapter (MAJ-1715) ..................................................................................................... 160
Probe driving unit ............................................................................................................... 161
6.4
Patient data ........................................................................................................... 163
6.5
Observation of ultrasound images ..................................................................... 166
Observation of B mode images .........................................................................................
Observation of FLOW mode images .................................................................................
Observation of PW mode images ......................................................................................
Observation of CH-EUS mode images ..............................................................................
Observation of ELST mode images ...................................................................................
166
168
169
171
173
6.6
Recording observed images ............................................................................... 174
6.7
Controlling the video system center .................................................................. 175
6.8
Terminating the operation .................................................................................... 175
Chapter 7 Functions ........................................................................... 177
7.1
Common functions (front panel) ......................................................................... 177
ACTIVE switch ................................................................................................................... 177
Access STOP switch ......................................................................................................... 179
7.2
Common functions (Keyboard) ........................................................................... 180
ID INPUT ...........................................................................................................................
SYS MENU ........................................................................................................................
DATABASE ........................................................................................................................
ADD DATA .........................................................................................................................
TIMER ...............................................................................................................................
DVR REMOTE ...................................................................................................................
SOCKET ............................................................................................................................
2D/3D ................................................................................................................................
MOVE DATA ......................................................................................................................
EXAM END ........................................................................................................................
SAVE/REC .........................................................................................................................
RELEASE ..........................................................................................................................
Selecting the ultrasound image (US mode) or endoscopic image (EVIS mode) ...............
CUSTOM ...........................................................................................................................
PIP (Picture-In-Picture) ......................................................................................................
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180
181
182
185
186
187
188
188
189
189
190
190
192
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B mode .............................................................................................................................. 194
FLOW mode ...................................................................................................................... 195
PW (Pulse Wave Doppler) mode ....................................................................................... 196
CURSOR ........................................................................................................................... 197
ADD (COMMENT) ............................................................................................................. 198
CLEAR (COMMENT) ......................................................................................................... 200
I. R. (Image Rotation) ........................................................................................................ 200
SCROLL ............................................................................................................................ 202
DEPTH/RANGE ................................................................................................................. 204
GAIN .................................................................................................................................. 206
ACOUSTIC OUTPUT ........................................................................................................ 207
FREEZE ............................................................................................................................ 208
CINE REVIEW ................................................................................................................... 209
CINE REVIEW (Trackball) .................................................................................................. 211
7.3
Mode selection ..................................................................................................... 212
Mode selection using keyboard ......................................................................................... 212
Mode selection using mode button on the touch panel ..................................................... 213
Mode selection using mode menu on the touch panel ...................................................... 214
7.4
Electronic scanning B mode ............................................................................... 215
Monitor display ..................................................................................................................
Keyboard operation ...........................................................................................................
Touch panel operations .....................................................................................................
Composition of menus .......................................................................................................
MAIN MENU ......................................................................................................................
IMAGE ADJUST ................................................................................................................
STC MENU ........................................................................................................................
MANUAL FOCUS MENU ..................................................................................................
Other touch panel menus ..................................................................................................
7.5
Electronic scanning FLOW mode ....................................................................... 241
Monitor display ..................................................................................................................
Keyboard operation ...........................................................................................................
Touch panel operations .....................................................................................................
Composition of menus .......................................................................................................
FLOW MAIN ......................................................................................................................
FLOW ADJUST .................................................................................................................
MAIN MENU ......................................................................................................................
IMAGE ADJUST ................................................................................................................
Other touch panel menus ..................................................................................................
7.6
216
220
220
221
222
231
234
236
240
242
246
246
247
248
258
259
259
259
Electronic scanning PW mode ............................................................................ 260
Monitor display ..................................................................................................................
Keyboard operation ...........................................................................................................
Touch panel operations .....................................................................................................
Composition of menus .......................................................................................................
PW MAIN ...........................................................................................................................
PW ADJUST ......................................................................................................................
PW FLOW .........................................................................................................................
MAIN MENU ......................................................................................................................
IMAGE ADJUST ................................................................................................................
Other touch panel menus ..................................................................................................
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7.7
Mechanical radial 2D scanning mode ................................................................. 288
Monitor display ..................................................................................................................
Keyboard operation ...........................................................................................................
Touch panel operations .....................................................................................................
Composition of menus .......................................................................................................
MAIN MENU ......................................................................................................................
IMAGE ADJUST ................................................................................................................
Other touch panel menus ..................................................................................................
7.8
Mechanical radial 3D scanning mode ................................................................. 294
Monitor display ..................................................................................................................
Keyboard operation ...........................................................................................................
Touch panel operations .....................................................................................................
Composition of menus .......................................................................................................
3D SETUP .........................................................................................................................
MAIN MENU ......................................................................................................................
IMAGE ADJUST ................................................................................................................
Other touch panel menus ..................................................................................................
7.9
288
290
290
291
292
293
294
296
304
304
305
306
316
316
316
Common touch panel menu ................................................................................ 317
MEASUREMENT ............................................................................................................... 317
COMMENT ........................................................................................................................ 318
PIP ..................................................................................................................................... 321
7.10 Electronic scanning CH-EUS mode .................................................................... 325
Selecting the electronic scanning CH-EUS mode .............................................................
Monitor display ..................................................................................................................
Keyboard operations .........................................................................................................
Touch panel operations .....................................................................................................
Composition of menus of CH-B mode ...............................................................................
Composition of menus of CH-COLOR mode .....................................................................
Electronic scanning CH-B mode ........................................................................................
CH-EUS MAIN ...................................................................................................................
CH-EUS ADJUST ..............................................................................................................
MAIN MENU ......................................................................................................................
Electronic scanning CH-COLOR mode .............................................................................
Selecting the electronic scanning CH-COLOR mode ........................................................
CH-EUS MAIN (CH-COLOR) ............................................................................................
CH-EUS ADJUST (CH-COLOR) .......................................................................................
CH-EUS COLOR ...............................................................................................................
MAIN MENU (CH-COLOR) ...............................................................................................
Other touch panels ............................................................................................................
326
328
332
334
335
336
337
337
346
348
348
348
349
350
351
351
351
7.11 Electronic scanning ELST mode ......................................................................... 352
Selecting the ELST mode ..................................................................................................
Monitor display ..................................................................................................................
Keyboard operations .........................................................................................................
Touch panel operations .....................................................................................................
Composition of menus .......................................................................................................
ELST MAIN menu ..............................................................................................................
STRAIN GRAPH ................................................................................................................
Set up of strain graph ........................................................................................................
Pressurization bar ..............................................................................................................
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358
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359
360
363
364
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MAIN MENU ...................................................................................................................... 371
IMAGE ADJUST ................................................................................................................ 371
Other touch panel menus .................................................................................................. 371
7.12 Data management ................................................................................................. 372
Summary of data management .........................................................................................
SAVE/REC data .................................................................................................................
Saving TIC movie ..............................................................................................................
Managing image data ........................................................................................................
Installing the portable memory ...........................................................................................
Removing the portable memory .........................................................................................
Selecting the data management function ..........................................................................
Database menu function ....................................................................................................
Open ..................................................................................................................................
Copy ..................................................................................................................................
Move ..................................................................................................................................
Delete ................................................................................................................................
TIC analysis .......................................................................................................................
Password setup .................................................................................................................
Move data ..........................................................................................................................
372
373
380
382
383
384
385
387
390
391
394
396
397
397
398
7.13 Operation of ancillary equipment (printer, DVR, etc.) ....................................... 401
Image printing using the monochrome video printer .........................................................
Image printing using the color video printer .......................................................................
Image saving using the portable memory via CV-190/290 ................................................
Image recording using the DVR ........................................................................................
Controlling the external storage device .............................................................................
Controlling the foot switch .................................................................................................
401
402
403
404
405
405
7.14 Control of the video system center .................................................................... 406
Touch panel menus for controlling the video system center .............................................. 407
Controlling the color video printer from the video system center ....................................... 418
Controlling the DVR from the video system center ............................................................ 420
7.15 Summary of image adjustments ......................................................................... 422
Classification of available functions ................................................................................... 422
Chapter 8 Measurement and Analysis .............................................. 425
8.1
Summary of measurement functions ................................................................. 425
8.2
Basic measurement ............................................................................................. 428
Distance measurement ......................................................................................................
Trace measurement ...........................................................................................................
Edit measurement .............................................................................................................
Clearing measurements .....................................................................................................
8.3
429
435
442
444
Measurements in the 3D mode ............................................................................ 445
Volume calculation ............................................................................................................. 445
Interpolation for trace measurement .................................................................................. 449
Ellipse approximation ........................................................................................................ 449
8.4
Measurement of saved still images .................................................................... 451
8.5
Measurements in the PW mode .......................................................................... 452
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Velocity measurement .......................................................................................................
Time measurement ............................................................................................................
Average velocity measurement .........................................................................................
Velocity ratio measurement ...............................................................................................
Time ratio measurement ....................................................................................................
Acceleration measurement ................................................................................................
PW trace measurement .....................................................................................................
PW MEASUREMENT MENU ............................................................................................
8.6
454
457
462
464
466
470
473
481
Measurement in the ELST mode ......................................................................... 488
Strain ratio measurement .................................................................................................. 490
Modifying the strain measurement .................................................................................... 494
8.7
TIC analysis ........................................................................................................... 500
TIC analysis flow ...............................................................................................................
Launching TIC analysis .....................................................................................................
TIC analysis menu .............................................................................................................
Setting the TIC analysis frames .........................................................................................
ROI setting tools for TIC analysis ......................................................................................
ROI locations in each frame for TIC analysis ....................................................................
TIC analysis result display .................................................................................................
TIC analysis result setting menu .......................................................................................
500
501
502
504
506
510
513
520
Chapter 9 Care, Storage, and Disposal ............................................ 523
9.1
Care ........................................................................................................................ 523
9.2
Storage .................................................................................................................. 525
9.3
Disposal ................................................................................................................. 525
Chapter 10 Troubleshooting ................................................................ 527
10.1 Troubleshooting ................................................................................................... 527
10.2 Troubleshooting guide ......................................................................................... 528
10.3 Messages and troubleshooting ........................................................................... 530
Message classification .......................................................................................................
Message for the user to take immediate action .................................................................
Malfunction message 1 ......................................................................................................
Malfunction message 2 ......................................................................................................
Setting confirmation message ...........................................................................................
Execution confirmation message .......................................................................................
End confirmation messages ..............................................................................................
530
531
531
532
534
538
539
10.4 Returning the Ultrasound Center for repair ....................................................... 540
Appendix ............................................................................................... 541
System chart .................................................................................................................. 541
Transportation, storage, and operation environment ................................................ 544
Specifications ................................................................................................................. 544
EMC information ............................................................................................................ 551
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Measurement accuracy ................................................................................................. 556
Equation for the pulse wave doppler measurement .................................................. 559
Transducer surface temperature (internal use) .......................................................... 562
License information of Open Source Software ........................................................... 563
GNU ................................................................................................................................... 563
Others ................................................................................................................................ 564
End User License Agreement of Open Source Software modules (English) ........... 565
GNU GENERAL PUBLIC LICENSE Version 2, June 1991 ...............................................
GNU GENERAL PUBLIC LICENSE Version 2 with Exception ..........................................
GNU LESSER GENERAL PUBLIC LICENSE Version 2.1, February 1999 ......................
Others ................................................................................................................................
565
572
573
583
Acoustic output safety / table ....................................................................................... 584
Maintenance ................................................................................................................... 634
Index ............................................................................................................................... 637
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Labels and Symbols
Labels and Symbols
Safety-related labels and symbols are marked on the locations shown below. If labels or symbols are
missing or illegible, contact Olympus.
Front panel
Refer to the instruction
manual.
ESD marking
Indicates a potential failure due
to electrostatic discharge. Do
not touch the terminal pins
directly with your hands.
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Labels and Symbols
Rear panel
Product name
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
MODEL OLYMPUS EU-ME2
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
MODEL OLYMPUS EU-ME2 PREMIER
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
MODEL OLYMPUS EU-ME2 PREMIER PLUS
Serial number
Manufacturer name
CE marking
Refer to the instruction
manual.
Crossed-out wheeled
bin symbol
Electric rating
Potential equalization
terminal
INPUT: 220–240 V
50/60 Hz, 370 VA
Back cover of this instruction manual
Symbol
Description
Manufacturer
Authorized representative in the European Community
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Important Information — Please Read Before Use
Important Information — Please Read Before Use
Intended use
This Ultrasound Center is intended to be used with Olympus ultrasound endoscopes, Olympus
ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time
ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic
ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract. Do not use this
device for any purpose other than its intended use.
Instruction manual
This instruction manual contains essential information on using this Ultrasound Center safely and
effectively. Before use, thoroughly review this manual and the manuals for all equipment that will be
used during the procedure and use the equipment as instructed.
Keep this and all related instruction manuals in a safe, accessible location. If you have any questions
or comments about any information in this manual, contact Olympus.
Terms used in this manual
Ultrasound endoscope:
“Ultrasound endoscope” includes ultrasound gastrovideoscopes and ultrasound
bronchofibervideoscopes.
Ultrasound probe:
Generic name indicating the Olympus ultrasound probe for endoscope or ultrasound probe
for 3D scanning.
Video system center:
The video system center is a device that converts video signals from a endoscope into
signals to display images on the monitor.
Video printer:
The video printer is a device that prints the frozen video image.
Wall mains outlet:
The wall mains outlet is a wall AC mains power outlet socket having an exclusive terminal
for grounding.
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Important Information — Please Read Before Use
Isolation transformer
The isolation transformer is a safety device that is used to isolate non insulated equipment
with potentially high leakage currents to decrease the possibility of an electric shock.
B mode
The B mode displays the brightness of received ultrasound signals.
FLOW mode
The FLOW mode displays the blood flow information calculated with Doppler processing.
The FLOW mode includes the COLOR FLOW, POWER FLOW, and H-FLOW modes.
COLOR FLOW mode
The COLOR FLOW mode displays velocity information calculated by Doppler processing.
POWER FLOW mode
The POWER FLOW mode displays amplitude information calculated by Doppler
processing.
H-FLOW (High Resolution Flow) mode
The H-FLOW mode displays amplitude information in a higher resolution than the POWER
FLOW mode. It also displays directions of the blood flow in color.
PW (Pulse Wave Doppler) mode
PW mode displays the blood flow information of only the regions of interest.
THE (Tissue Harmonic Echo) mode
Imaging method that uses the harmonic component bounced back from the tissue.
CH-EUS (Contrast Harmonic EUS) mode
Mode for imaging using the harmonic component from the ultrasound contrast agent.
The CH-EUS mode includes two modes; the CH-B mode and the CH-COLOR mode.
CH-B (Contrast Harmonic B) mode
Mode for viewing the harmonic component from the ultrasound contrast agent using
dedicated B mode images.
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Important Information — Please Read Before Use
CH-COLOR (Contrast Harmonic COLOR) mode
Mode for viewing the harmonic component from the ultrasound contrast agent by
superimposing a color image on a fundamental image.
Fundamental image
Reference image in the CH-EUS mode.
ELST (Elastography) mode
Mode for displaying the relative elasticity information of a tissue using color images.
2D scanning
2D scanning is an examination displaying the ultrasound images in two dimensions.
3D scanning
3D scanning is an examination displaying the ultrasound images in three dimensions.
Helical scanning
Ultrasound probe is moved linearly and rotated simultaneously to acquire ultrasound
images with spiral scanning.
3D display
In 3D examination, 3D display is achieved by rebuilding multiple, consecutive 2D images
acquired by 3D scanning.
DPR (Dual Plane Reconstruction)
DPR display is based on helical and radial scanning with the probe driving unit and the
ultrasound probe for 3D scanning.
MPR (Multi Plane Reconstruction)
The MPR display shows radial images, vertical helical images, horizontal images, and
oblique images on a screen divided into four parts during 3D examination.
GI
Gastrointestinal.
PB
Pancreas and bile duct.
RSP
Respiratory organ (bronchus).
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Important Information — Please Read Before Use
Dual-screen display
It is possible to select the dual-screen display for displaying the B mode and FLOW mode
simultaneously on the screen split into two areas or to select the single-screen display for
overlapping the FLOW mode on the B mode. The images that can be viewed in the
single-screen display and dual-screen display are variable depending on the mode.
Stroke
The stroke is the movement range of helical scanning in the direction of the insertion axis.
Pitch
The pitch is the interval of movement in helical scanning.
Freeze
The freeze function creates a stationary ultrasound image and the ultrasound transmission
is stopped.
Release
The release function is used to capture and record an ultrasound image.
STC (Sensitivity Time Control)
Indication of the brightness adjustment condition at each distance from the ultrasound
transducer.
Focus
Focus is the function that improves the resolution in a chosen area of the ultrasound
image.
ENHANCE
ENHANCE is the function that executes the image enhancement specialized for the B
mode images.
COMPOUND
COMPOUND is the function that superimposed image obtained from ultrasound signals
sent from different angles.
Frame rate
The numbers displayed on the screen represent the frames updated per second, which are
rough numbers for information.
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Important Information — Please Read Before Use
ROI
It is regions of interest.
TIC (Time Intensity Curve) analysis
When multiple ROI are set during playback of a movie recorded in the CH-B mode and
THE mode, the change over time of the average brightness of each ROI can be displayed
in the graphic forms.
ALARA (As Low As Reasonably Achievable)
The ALARA is the guiding principle of ultrasound use, which states that you should keep
patient exposure to ultrasound radiation as low as reasonably achievable for diagnostic
results.
Acoustic power
Acoustic power is the intensity of the ultrasound output from an ultrasound endoscope or
probe.
TI (Thermal Index)
The TI is an indication of the probability of occurring thermal bioeffects: the higher the TI,
the greater the probability of thermal bioeffects.
MI (Mechanical Index)
The MI is an indication of the probability of occurring mechanical bioeffects: the higher the
MI, the greater the probability of mechanical bioeffects.
Administrator
A person who manage the Ultrasound Center.
Database user
A person who open, copy, or move data stored in the Ultrasound Center.
Arrow pointer
Displays the green arrow mark by CURSOR key.
Cursor
Displays the white arrow mark on the menu display or white blinking box cursor in
comment mode.
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User qualifications
If there is an official standard on the qualification of endoscopy and endoscopic treatment that is
defined by the medical administration or other official institutions such as the academic society on
endoscopy, follow the standard. If there is no official qualification standard, the operator of the
Ultrasound Center must be a physician approved by the medical safety manager of the hospital or
person in charge of the department (department of urology, etc.). The medical safety manager of the
hospital or person in charge of the department should select a physician who is performing the planned
endoscopic treatment safety by following the official guidelines set by the academic society of
endoscopy, etc.
Instrument compatibility
Refer to “System chart” on page 541 to confirm that the Ultrasound Center is compatible with the
ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment
damage and makes it impossible to obtain the expected functionality.
The Ultrasound Center complies with the EMC standard for medical electrical equipment; edition 3
(IEC 60601-1-2: 2007), edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument
that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993),
the whole system complies with edition 1.
Repair and modification
Never attempt to disassemble or modify the instrument, as this may result in patient or operator injury
as well as damage to the equipment. In addition, the functionality of the instrument can not be
guaranteed. If the instrument seems to require repair, first take measures by referring to Chapter 10,
“Troubleshooting”. If the problem still persists, contact Olympus.
This instrument is to be repaired by Olympus technicians only. Olympus is not liable for any injury or
damage that occurs as a result of repairs attempted by non-Olympus personnel.
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Signal words
The following signal words are used throughout this manual.
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. It may also be used to alert against unsafe practices or potential
equipment damage.
NOTE
Indicates additional helpful information.
Dangers, warnings, and cautions
Follow the dangers, warnings, and cautions given below when handling the Ultrasound Center. This
information is to be supplemented by the dangers, warnings, and cautions given in each chapter.
DANGER
• Strictly observe the following precautions. Failure to do so may place the patient
and medical personnel in danger of an electric shock:
When this Ultrasound Center is used in a patient examination, do not allow
metal parts of the ultrasound endoscope or its accessories to touch metal parts
of other system components. Such contact may cause unintended current flow
to the patient.
Keep fluids away from all electrical equipment. If fluids are spilled on or into the
unit, stop operation of the Ultrasound Center immediately and contact Olympus.
Do not prepare, inspect, or use this Ultrasound Center with wet hands.
• Never install and operate the Ultrasound Center in locations where:
The concentration of oxygen is high;
Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere;
Flammable gases are present in the atmosphere;
Flammable liquids are near.
An explosion or a fire may result because the video system center is not
explosion-proof.
• Use only a grounded wall mains outlet when connecting the Ultrasound Center.
Failure to do so may cause an electric shock or a fire.
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DANGER
• To avoid the risk of an electric shock and/or a fire, inspect the power cord and the
plug on a regular basis. Do not use them if they are damaged.
WARNING
• When the Ultrasound Center is used in conjunction with any other electrical device,
always ensure that the device has undergone a full safety check and the isolation
transformer recommended by Olympus is used to avoid an electric shock.
• Do not place objects on or near the ventilation grills of the Ultrasound Center while
it is in use.
• When using a high-frequency EndoTherapy accessory, electrosurgical unit,
electrosurgical accessories, or laser accessories, refer to the instruction manuals
for the ultrasound endoscopes or ultrasound probes. Otherwise, the patient and/or
user may receive an electric shock, a fire may be caused, and the ultrasound
endoscope or ultrasound probe may be damaged.
• This product may interfere with other medical electronic equipment used in
combination with it. Before use, refer to “Appendix” to confirm the electromagnetic
compatibility of the Ultrasound Center with all equipment to be used.
• Do not use this Ultrasound Center in locations exposed to strong electromagnetic
radiation (for example, in the vicinity of a microwave therapeutic device, MRI,
wireless set, short-wave therapeutic device, cellular/portable phone, etc.). This may
impair the performance of the Ultrasound Center.
• Use the power cord provided with this Ultrasound Center. Using any other power
cord may lead to malfunction of the Ultrasound Center or burnt power cord. Note
that this power cord is dedicated to this Ultrasound Center and it must not be used
for any other product.
• The SDI signal is transmitted by daisy-chaining (chaining in a row) several devices.
If one of the devices is turned OFF, the SDI signal is not transmitted to the rest of
them.
CAUTION
• Do not place the product on its side. Otherwise, the Ultrasound Center may fall and
become damaged and/or cause injury.
• Do not use the Ultrasound Center under conditions other than those specified in
“Transportation, storage, and operation environment” on page 544.
• Do not use a pointed or hard object to press the keys on the keyboard. This could
damage the keyboard.
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CAUTION
• To prevent unnecessary patient exposure to ultrasound radiation, follow the
“as-low-as-reasonably achievable” (ALARA) principle when using 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
ultrasound radiation is emitted.
• Do not touch the electrical contacts inside the Ultrasound Center’s socket.
Otherwise, the Ultrasound Center may be damaged.
• Do not apply excessive force to this Ultrasound Center and/or other instruments
connected. Otherwise, damage and/or malfunction can occur.
• Do not use the Ultrasound Center in a dusty environment. Otherwise, damage
and/or malfunction can occur.
• When necessary, clean and vacuum the ventilation grills and filter using a vacuum
cleaner. Otherwise, the Ultrasound Center may break down and be damaged by
overheating.
• Be sure that the Ultrasound Center is not used adjacent to or stacked with other
equipment (other than the components of the Ultrasound Center or system) to
avoid electromagnetic interference.
• When using the ultrasound endoscope or probe in conjunction with an X-ray
device, electrical noise may appear in the ultrasound image.
• Electromagnetic interference may occur to the Ultrasound Center when it is placed
near equipment marked with the following symbol or other portable and mobile RF
communications equipment such as cellular phones. If radio interference occurs,
mitigation measures may be necessary, such as reorienting or relocating the
Ultrasound Center or shielding the location.
• Do not touch the connectors labeled with the following symbol when turning ON the
power or during use. Turn the Ultrasound Center OFF, or turn the ACTIVE switch
OFF and confirm the ACTIVE lamp is not illuminated. Before inserting or removing
the connectors. Otherwise, malfunction may occur.
• This Ultrasound Center is not indicated to be able to use for fetus and eye. Do not
use this Ultrasound Center for fetus and eye.
NOTE
The Ultrasound Center complies with IEC 60601-2-37 standard and the system
always monitors if the Ultrasound Center is working in a normal condition. When an
abnormal condition is detected, the ultrasound output is stopped by the software.
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Cardiac applications
DANGER
Because the Ultrasound Center is a TYPE BF applied part, the ultrasound
endoscope connected to it must never be applied directly to the heart. Leakage
current from a TYPE BF applied part may be dangerous and could cause
ventricular fibrillation or otherwise seriously affect the cardiac function of the
patient.
Accordingly, always adhere to the following points:
Never apply the ultrasound endoscope connected to this Ultrasound Center to
the heart or any area near the heart.
Never allow an EndoTherapy accessory or another ultrasound endoscope
applied to or near the heart to come in contact with the ultrasound endoscope
connected to this Ultrasound Center.
NOTE
As defined by the international safety standard (IEC 60601-1), medical electrical
equipment is classified into the following types: TYPE CF applied parts (the
instrument can safely be applied to any part of the body, including the heart), and
TYPE BF applied parts (the instrument can safely be applied to any organ except
the heart). The part of the body that an endoscope or electrosurgical accessory can
safely be applied to depends on the classification of the equipment to that the
instruments are connected. Before beginning the procedure, check the current
leakage classification type of each instrument to be used for the procedure.
Classification types are clearly specified in the instrument’s instruction manuals.
Symbol
Classification
TYPE CF applied part
TYPE BF applied part
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ALARA principle
ALARA “as low as reasonably achievable” is the guiding principle for the use of diagnostic ultrasound.
Qualified medical professionals, using good judgement and insight, determine the exposure that is as
low as reasonably achievable. There are no sufficient rules to determine the correct response to every
situation. Therefore it is the responsibility of the physician to keep exposure low, bioeffects minimal,
and images diagnostic.
A thorough knowledge of the imaging modes, transducer capability, system setup, and scanning
technique is necessary. The imaging mode determines the nature of the ultrasound beam. Transducer
capability depends upon transducer frequency, penetration, resolution, and field of view. It is the
scanning technique of the qualified ultrasound user along with patient variability that determine the
system setting throughout the examination.
There are variables that affect the way the physician implements the ALARA principle. These variables
include body size, location of the bone relative to the focal point, attenuation in the body, and
ultrasound exposure time. Exposure time is an especially useful variable because it can be controlled
by the physician. The ability to limit the exposure over time supports the ALARA principle.
Applying ALARA
The system imaging mode selected by the physician is determined by the information required.
B mode imaging (both 2D and 3D imaging) provides anatomical information; FLOW mode
imaging provides the blood flow information calculated with Doppler processing; PW mode
imaging provides the blood flow information of only the regions of interest; CH-EUS mode
imaging provides information of the harmonic component from the ultrasound contrast agent:
ELST mode imaging provides tissue elasticity information.
Understanding the nature of the imaging mode being used allows the trained physician to apply
the ALARA principle.
Prudent use of ultrasound implies that the patient exposure to ultrasound is limited to the lowest
output for the shortest time necessary to achieve acceptable diagnostic results.
The physician uses the system controls to adjust image quality and ultrasound output.
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Reference materials
(1) Medical Ultrasound Safety, American Institute of Ultrasound in Medicine, 1994
(2) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA
UD2–2004, American Institute of Ultrasound in Medicine
(3) Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment, American
Institute of Ultrasound in Medicine, 2008
(4) Standard for Real–Time Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment: NEMA UD3-2004, American Institute of
Ultrasound in Medicine.
(5) IEC 60601-2-37: 2007,
Medical electrical equipment – part 2–37: Particular requirements for the basic safety
and essential performance of ultrasonic medical diagnostic and monitoring equipment
(6) Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers, FDA, 2008
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