Aplio iXXX TUS-AIxxx series Operation Manual Fundamentals July 2019

Introduction This operation manual describes the operating procedures for the diagnostic ultrasound system TUS-AI900/TUS-AI800/TUS-AI700. To ensure safe and correct operation of the system, carefully read and understand the manual before operating the system.

Trademarks Windows® is a registered trademark of Microsoft Corporation in the United States and other countries. Ultra-Pro ΙΙ, BX2, Verza, AccuSITE, VirtuTRAX, and omniTRAX are trademarks of CIVCO Medical Solutions. Clorox Healthcare is a trademark of The Clorox Company. SANI-CLOTH is a registered trademark of Professional Disposables International, Inc. Dispatch is a registered trademark of The Clorox Company. Cleanisept is a registered trademark of Dr. Schumacher GmbH. BIOSPOT is a registered trademark of HydraChem Limited. Java is a registered trademark of Oracle and/or its affiliates. ApliPure, MicroPure, TwinView, and Dynamic Flow are trademarks of Canon Medical Systems Corporation. This manual may also include trademarks or registered trademarks of other companies. Note that the trademark symbol "" and the registered trademark symbol "" may or may not be used in this manual.

IMPORTANT! 1. No part of this manual may be copied or reprinted, in whole or in part, without prior written permission. 2. The contents of this manual are subject to change without prior notice and without legal obligation. 3. The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or erroneous descriptions, missing information, etc.

No. 2B771-141EN*Y

Organization of the Operation Manuals 1.

Notation Conventions

In this operation manual, the following word is used in addition to the signal words related to the safety precautions (refer to section 2 "General Safety Information"). Please read this operation manual before using the system. NOTE:

2.

Indicates reference information that enables more efficient use of the equipment.

Operation Manuals

A Canon Medical Systems service person or instructor will explain the basic operating procedures for this system at the time of delivery. However, read this operation manual carefully before using the system in order to understand the detailed operating procedures, functions, performance, and maintenance procedures. Operation manual for the main unit of the ultrasound system Fundamentals volume (this manual)

Applications volume

... Describes the basic information concerning the system, such as preparation for examination, operation, inspection, and functional descriptions of the system. ... Describes the exam data manipulation procedures and operation procedures for each application.

Optional applications volume

... Describes the operation procedures for each application (option).

Measurements volume

... Describes the registration and measurement procedures.

Acoustic power and surface temperature data

... Describes the acoustic power transmitted from ultrasound transducers.

Quick guide

... Describes the frequently used functions and basic operations.

Operation manual for each transducer

... Describes the operating and disinfection/sterilization procedures for the transducer.

No. 2B771-141EN*Y 3

NOTE:

NOTE:

3.

The manual numbers of the manuals available in English are as follows: • 2B771-141EN

Fundamentals volume (This manual)

• 2B771-142EN

Applications volume

• 2B771-376EN

Optional applications volume

• 2B771-143EN

Measurements volume

• 2B771-144EN/308EN

Acoustic power and surface temperature data (For regions other than the USA and Canada)

• 2B771-145EN

Acoustic power and surface temperature data (For the USA and Canada only)

• 2B771-147EN

Quick guide

The operation manuals Applications volume, Optional applications volume, and Measurements volume may be supplied on electronic media.

Switch Configuration

• The descriptions in this operation manual are based on the standard switch configuration. If the switch configuration has been changed, the differences between the current configuration and the standard configuration must be understood before use. • The layout, shapes, labels, and icons of the switches on the touch panel can be changed. All the figures of the touch panel and switches in this manual are examples and may differ from the actual display.

4.

Operating Switches and Display of the Touch Panel

• Some operations can be performed using either the switches on the main panel or the corresponding switches on the touch panel. • The switches displayed on the touch panel, the switch layout, and the number of tabs differ depending on the mode, the region examined, the transducer selected, and the presets.

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Table of Contents Organization of the Operation Manuals················································ 3 1.

Intended Use ... 13

1.1

Intended Use/Indications for Use... 13

1.2

Transducers ... 13

1.3

Intended Patient Information ... 13

1.4

Intended User Profile ... 13

1.5

Operating Principles... 13

2.

General Safety Information ... 15

2.1

Meaning of Signal Words ... 15

2.2

Meaning of Safety Symbols... 15

2.3

Ensuring the Safety of Patients and Operators ... 16

2.4

Preventing Electric Shocks, Fires, and Power Supply Interruptions ... 18

2.5

Chemical Hazard ... 20

2.6

Electromagnetic Compatibility (EMC) ... 21

2.7

Acoustic Power... 22

2.8

Preventing System Malfunctions ... 23

2.9

Handling Patient and Image Data... 25

2.10

Precautions for Cybersecurity ... 26

2.11

Warning Labels ... 27

2.12

Regulatory Labels ... 33

2.13

Precautions Concerning Clinical Examination Techniques ... 33

3.

General Information on Usage and Maintenance ... 34

4.

Use Conditions ... 37

4.1

Power and Environmental Requirements... 37

4.2

Environmentally Friendly Usage and Maintenance Management... 38

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5.

System Configuration ... 39

5.1

Standard Configuration... 39

5.2

List of Optional Items ... 40

5.3

Compatible Peripheral Devices ... 47

5.4

External Storage Devices ... 47

5.5

DICOM Devices ... 47

5.5.1

Interface for connection to DICOM devices ... 47

5.5.2

DICOM-related functions ... 47

5.6

List of Available Transducers... 50

5.7

Transducer Cable Length ... 56

5.8

Cables That Can Be Connected... 57

6.

Names and Functions of Sections ... 58

6.1

Names of Sections ... 58

6.2

Main Panel ... 59

6.3

Rear Panel ... 63

6.4

Symbols and Labels on the Systems ... 64

6.4.1

Symbols... 64

6.4.2

Labels... 65

6.4.3

Cargo handling marks (care marks) ... 77

7.

Preparation for Examination ... 78

7.1

Moving and Installing the System ... 78

7.2

Handling and Connection/Disconnection of Transducers ... 82

7.2.1

Handling of transducers ... 82

7.2.2

Connection/Disconnection of transducers ... 82

7.3

Adjusting the Main Panel ... 84

7.4

Adjusting the Touch Panel Angle ... 86

7.5

Adjusting the Monitor ... 87

7.5.1

Locking and releasing the monitor ... 87

7.5.2

Adjusting the angle of the monitor ... 88

7.5.3

Adjusting the monitor display ... 89

7.6

Handling of USB Connectors... 90

8.

Checks Before and After Use ... 91 No. 2B771-141EN*Y 6

8.1

Checks Before Turning ON the Power... 91

8.2

Checks After Turning ON the Power ... 92

9.

Turning the Power ON/OFF ... 94

9.1

Connecting the Power Cable and the Protective Grounding ... 95

9.2

Turning ON the Power ... 96

9.3

Turning OFF the Power ... 98

9.4

System Operation in Battery Mode ... 101

9.4.1

Operation in battery mode... 102

9.4.2

Monitor display ... 102

9.4.3

Charging the battery ... 104

9.4.4

Replacement of the battery ... 105

9.5

Standby Mode ... 106

9.5.1

Setting Standby mode ... 107

9.5.2

Recovery from the Standby status... 110

9.6

Preparation for Use in Emergency Cases or Use During Surgery... 112

9.6.1

Preparation of a backup system ... 112

9.6.2

Turning the power OFF and then back ON in the case of system failure ... 112

10.

Basic Screen ... 113

10.1

Display of Various Data Items ... 113

10.2

Displaying the Acoustic Power Data ... 114

10.3

Thumbnail Display... 116

10.4

Display of Scanning Direction... 119

11.

Starting an Examination ... 120

11.1

Entering Patient Details and Starting the Examination ... 121

12.

Reference Signal Display... 125

12.1

Reference Signal Panel ... 128

12.2

Connecting the Reference Signal Sensor Cables... 129

12.3

Adjusting Reference Signals ... 129

12.3.1

[PHYSIO] menu and reference signal display ... 129

12.3.2

Adjustment using the touch panel ... 130 No. 2B771-141EN*Y 7

13.

Operations Common to All Modes ... 133

13.1

Touch Panel Operation... 133

13.2

Screen Display of Each Menu... 135

13.3

Function Menu ... 137

13.4

Shortcut Menu ... 141

13.5

Software Keyboard... 142

13.6

Multifunction Switches ... 144

13.6.1

Multifunction operation area... 144

13.6.2

Multifunction display area ... 144

13.6.3

Trackball function assignment... 145

13.7

Switching the Imaging Preset During Examination ... 146

13.7.1

Switching to a registered imaging preset ... 146

13.7.2

Switching to the default imaging presets... 149

13.8

Switching the Transducer During Examination ... 152

14.

Display and Operation in Each Mode ... 153

14.1

2D Mode ... 153

14.1.1

2D screen layout ... 154

14.1.2

Adjustment using the main panel ... 155

14.1.3

Adjustment using the multifunction switches ... 156

14.1.4

Adjustment using the touch panel ... 158

14.1.5

Selection of image zooming method ... 161

14.1.6

Trapezoid scan/curved vector scan ... 163

14.1.7

BEAM (Biopsy Enhancement Auto Mode) ... 164

14.2

M Mode ... 166

14.2.1

M screen layout ... 167

14.2.2

Adjustment using the main panel ... 168

14.2.3

Adjustment using the multifunction switches ... 169

14.2.4

Adjustment using the touch panel ... 170

14.3

CDI Mode ... 172

14.3.1

CDI display layout ... 173

14.3.2

Adjustment using the main panel ... 174

14.3.3

Adjustment using the multifunction switches ... 175

14.3.4

Adjustment using the touch panel ... 176

14.4

Power Mode... 178

14.4.1

Power display layout... 178 No. 2B771-141EN*Y 8

14.4.2

Adjustment using the main panel ... 178

14.4.3

Adjustment using the multifunction switches ... 178

14.4.4

Adjustment using the touch panel ... 178

14.5

SMI Mode (Superb Microvascular Imaging Mode) ... 181

14.5.1

SMI display layout ... 181

14.5.2

Adjustment using the main panel ... 181

14.5.3

Adjustment using the multifunction switches ... 181

14.5.4

Adjustment using the touch panel ... 182

14.6

TDI Mode (Tissue Doppler Imaging Mode)... 184

14.6.1

TDI display layout ... 184

14.6.2

Adjustment using the main panel ... 184

14.6.3

Adjustment using the multifunction switches ... 184

14.6.4

Adjustment using the touch panel ... 184

14.7

Doppler Mode ... 186

14.7.1

Doppler display layout ... 186

14.7.2

Adjustment using the main panel ... 187

14.7.3

Adjustment using the multifunction switches ... 189

14.7.4

Adjustment using the touch panel ... 190

15.

Cine Function ... 193

15.1

Overview ... 193

15.2

Cine Operations... 193

15.2.1

Operations using the multifunction switches ... 193

15.2.2

Operations using the touch panel ... 195

15.3

Select R-R Function ... 197

15.3.1

Setting the unit for specification of the playback range and the default playback range... 198

15.3.2

Setting the playback range ... 199

16.

Body Marks ... 200

16.1

Body Mark Mode ... 200

16.2

Setting and Editing Body Marks ... 201

16.2.1

Body mark menu ... 201

16.2.2

Displaying a body mark ... 202

17.

Entering Comments ... 204

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17.1

Entering and Exiting Annotation Mode ... 204

17.1.1

Displaying the annotation entry screens ... 204

17.1.2

Closing the annotation entry screen ... 204

17.2

Entering and Editing Annotations ... 205

17.2.1

Annotation menu ... 205

17.2.2

Inserting an annotation ... 206

17.2.3

Editing annotations ... 208

18.

Needle Mark ... 211

18.1

Applicable Transducers and Biopsy Adapters ... 213

18.2

Needle Mark Display and Angle Change Procedures ... 219

18.2.1

Needle mark display... 219

18.2.2

Needle mark angle change procedures ... 223

19.

Storing Image Data ... 224

19.1

Setting the Save Conditions ... 224

19.2

Auto Store ... 225

19.3

Still Store ... 225

19.4

Storing Dynamic Images ... 226

19.4.1

Dynamic image storage format ... 226

19.4.2

Dynamic image storage methods ... 227

19.4.3

Saving Cine images... 229

19.4.4

Auto Review ... 230

19.4.5

Setting of the storage format (for retrospective storage) ... 232

19.5

File Handling for Image Data ... 232

19.6

Displaying Saved Images ... 232

20.

Maintenance ... 233

20.1

Technical Descriptions... 233

20.2

Outline of Preventive Maintenance ... 233

20.3

Preventive Maintenance Performed by the User ... 234

20.3.1

Cleaning the system ... 234

20.3.2

Disinfecting the system ... 242

20.3.3

Creating a backup copy of the system hard disk... 245

20.3.4

[Maintenance] menu... 245

20.3.5

Backing up the customer-specific data (Backup) ... 246 No. 2B771-141EN*Y 10

20.4

Preventive Maintenance Performed by Service Personnel ... 249

20.5

Consumable Parts ... 249

20.6

Checks During Storage ... 249

21.

Disposal ... 250

22.

Checks Before the System Is Judged Defective ... 251

23.

Specifications ... 253

23.1

External Dimensions and Mass ... 253

23.2

Essential Performance of This System ... 253

23.3

Conformance Standards ... 254

23.4

Safety Classification... 255

23.5

Accuracy of Measurement ... 256

24.

Using MI/TI ... 257

24.1

Using MI/TI (Outside the USA and Canada) ... 257

24.1.1

Basic knowledge of MI/TI ... 257

24.1.2

MI/TI display description... 259

24.1.3

Parameters affecting the MI/TI values ... 260

24.1.4

Operating procedures for MI/TI ... 261

24.1.5

Output display ... 262

24.1.6

Reminder ... 262

24.1.7

Ultrasonic output power and acoustic output ... 263

24.1.8

References for MI/TI ... 264

24.2

Using MI/TI (In the USA and Canada) ... 265

24.2.1

Basic knowledge of MI/TI ... 265

24.2.2

MI/TI display description ... 267

24.2.3

Parameters affecting the MI/TI values ... 268

24.2.4

Operating procedures for MI/TI ... 269

24.2.5

Output display ... 270

24.2.6

Information contained in the system documentation ... 271

24.2.7

Measurement uncertainty and precision ... 271

24.2.8

Reminder ... 271

24.2.9

Ultrasonic output power and acoustic output ... 272

24.2.10

References for MI/TI ... 274 No. 2B771-141EN*Y 11

25.

Guidance and Manufacturer's Declaration ... 275

26.

Intellectual Property ... 282

26.1

Availability of This Software and Related Documents Is Restricted. ... 282

26.2

Agreement for Microsoft Software ... 282

26.3

Others ... 292

27.

Indication of Year of Manufacture ... 331

28.

Electronic Instructions for Use ... 332

No. 2B771-141EN*Y 12

1. Intended Use 1.1

Intended Use/Indications for Use The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, transrectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), and laparoscopic.

1.2

Transducers For the transducers that can be used with this system and their applications, refer to subsection 5.6 "List of Available Transducers".

1.3

Intended Patient Information • Age, health condition: Not specified However, do not use this system if the patient's condition may lead to the patient being exposed to hazard.

1.4

Intended User Profile • Only physicians or legally qualified persons who have received appropriate training Before using this system, it must be ensured that the user has received sufficient training.

1.5

Operating Principles This diagnostic ultrasound system transmits ultrasound signals into the human body from a transducer and receives the reflected echoes from the human body using the same transducer. It then processes the received signals and displays them as images on a display screen (LCD monitor). Gating signals are sent from the scan control circuit through the transmission delay circuit and are input to the reception circuit. The reception circuit then generates the transmission signals (electrical pulses) according to the gating signals. These electrical pulses are applied to piezoelectric elements that convert the electrical signals into mechanical vibrations in the transducer. These mechanical vibrations, which are ultrasound signals, are then transmitted into the human body. This system supports various scanning techniques, including convex, sector, and linear scanning. When the ultrasound signals transmitted into the human body encounter a substance with different acoustic characteristics, they are reflected and return to the transducer as echoes. Based on the time required for the ultrasound signals to return to the transducer, the distance between the transducer surface and the reflecting substance can be determined.

No. 2B771-141EN*Y 13

In 2D (B) mode imaging, the echo amplitudes are represented as brightness changes on the image display screen. Since the ultrasound beam attenuates in tissue, the degree of amplification required generally increases as depth increases. Regions of high reflection appear brighter, while regions of low reflection appear darker. An M-mode image (cross-sectional image) can be displayed together with a 2D-mode image on the same screen through time-sharing control, allowing the user to perform M-mode diagnosis while observing a 2D-mode image. The system creates and displays real-time 3D images as dynamic images (4D Imaging (2DA)) by performing ultrasound 3D electronic scanning inside the body with the 2D electronic array transducers. In color Doppler imaging, phase detection is performed in a receive signal processing circuit to obtain I and Q signals. These signals undergo frequency analysis with the correlational method in a color Doppler imaging circuit to produce the mean velocity, variance, and power information of the blood flow. These information items are assigned color signals and are represented as real-time color Doppler images. In Doppler imaging, the signals output from the receive signal processing board are frequency-analyzed by fast Fourier transformation (FFT) in a Doppler circuit to produce velocity and power information. A Doppler image is then displayed, plotting velocity on the vertical axis, time on the horizontal axis, and representing power as brightness. This system supports basic measurements including distance, time, angle, and trace, as well as combinations of some basic measurements. In addition, calculations based on the measurement values can be performed for each region (circulatory system, OB, etc.) using widely accepted empirical formulas. The calculation results can be displayed as values, tables, or graphs. This is a general-purpose diagnostic ultrasound system that supports a variety of external and internal scanning methods. In addition, the system configuration can be changed in order to use the system as a specialized cardiovascular diagnostic ultrasound system for visualizing cardiac anatomical abnormalities, analyzing blood flow characteristics, and evaluating structural and functional changes associated with myocardial infarction. This system allows measurement of the stiffness of organs etc. using the following functions (option). Displacement of body tissues in the depth direction generated by extremely small external force applied to the body surface is detected using the ultrasound pulse reflection method. In this method, indices such as Young's modulus and the propagation velocity of shear waves (which is highly correlated with tissue stiffness) are measured and displayed. External force is applied using either of the following 2 methods. • Shear Wave Elastography :

External force is applied using push pulses.

• Strain Elastography

External force is applied by manual compression.

:

No. 2B771-141EN*Y 14

2. General Safety Information This section describes the general precautions and details that must be observed when using this system. Precautions related to specific operations are described in the corresponding sections. When using the system, be sure to also read the precautions in the Operation Manual <<Measurements volume>>, the Operation Manual <<Applications volume>>, and the Operation Manual <<Optional applications volume>>, respectively.

2.1

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

Meaning

DANGER

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

WARNING

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

CAUTION

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

NOTICE

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

In addition to the above, the signal word NOTE is used to indicate other important information. NOTE

2.2

Indicates reference information that enables more efficient use of the equipment.

Meaning of Safety Symbols Symbol

Description Type-BF applied part *

Type BF when Type-BF applied parts are connected. The ultrasound transducers, ECG electrodes, heart sound sensor, and pulse wave sensor that can be connected to this system are Type-BF applied parts.

"Attention" (Refer to the operation manuals.)

No. 2B771-141EN*Y 15

2.3

Ensuring the Safety of Patients and Operators Observe the following safety precautions to ensure the safety of patients and operators.

DANGER:

This system must be used only when the potential benefits to the patient are judged to outweigh the possible risk to the patient.

WARNING: 1. Do not use damaged or defective transducers. Doing so may result in injury to the patient.

2. Take special precautions when examining a patient with high temperature. A high patient temperature may slow down cooling of the transducer surface, which may result in a burn injury to the patient. If the surface temperature of the transducer becomes abnormally high, stop using the transducer and contact your Canon Medical Systems service representative. 3. This device is contraindicated for ophthalmic use or any application that causes the acoustic beam to pass through the eye. 4. Do not look inside the DVD/CD unit. The emitted laser beam is hazardous to the eyes and other parts of the body. 5. Prolonged and repeated use of hardware keyboards (option) can result in hand or arm nerve disorders in some individuals. Observe the local institutional work safety/health regulations on keyboard use. 6. Do not use the Fusion function (option) for patients who use electronic life-support devices (for example, a cardiac pacemaker or defibrillator). The magnetic field generated in Fusion mode may affect such devices.

CAUTION: 1. Do not use the transducer on the same region of the patient

for a prolonged period. Low temperature burns may occur. Use the transducer for the minimum period of time that is required for diagnosis. Though the transducer surface temperature may exceed the patient's body temperature under some ambient conditions and usage modes, the use of the transducer for normal ultrasound diagnosis is unlikely to cause low temperature burns.

2. Do not sit on the system. Doing so may result in the system moving unexpectedly, causing you to lose your balance and fall.

No. 2B771-141EN*Y 16

CAUTION: 3. When this system is used to examine an elderly patient or an infant, an attendant should be present if required.

4. Do not perform Shear Wave scanning (option) for the fetus and uterus during pregnancy. The Shear Wave function uses "Acoustic Radiation Force Impulse". The guidelines "Bioeffects related to imaging equipment that uses acoustic radiation force" and "Effects on biological tissues exposed to ultrasound with acoustic radiation force impulse" (in Japanese) provided by the Ultrasound Equipment and Safety Committee of The Japan Society of Ultrasonics in Medicine must be observed when using the Shear Wave function. 5. When executing Smart Navigation, note that the VirtuTRAX bracket manufactured by CIVCO has an expiration date. Never use a bracket after its expiration date has passed.

TM

6. When executing Fusion (Smart Fusion), note that the magnetic-sensor bracket (for CT and MR) manufactured by CIVCO has an expiration date. Never use a bracket after its expiration date has passed. 7. Use a new magnetic sensor bracket for every examination.

No. 2B771-141EN*Y 17

2.4

Preventing Electric Shocks, Fires, and Power Supply Interruptions Observe the following safety precautions to prevent electric shocks, fires, and power supply interruptions.

DANGER:

Never use flammable or explosive gases near this system. Also do not use the system with oxygen or in an oxygenenriched atmosphere. Doing so may result in an explosion (the system is not explosion-proof).

WARNING: 1. Follow the instructions below regarding the power cable and plug.

• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective grounding. • Insert the power plug only into a 3-pin medical electrical outlet (with protective grounding). • Do not connect the power cable to a 2-pin outlet using an adapter. • Do not forcibly bend the cable. • Do not modify the power cable or plug. • Do not damage the power cable or plug. • Do not twist the power cable or plug. • Do not bundle the power cable or plug. • Do not place heavy objects on the power cable or plug. • Do not pinch the power cable or plug. • Do not subject the power cable or plug to impact. • Do not pull the power cable to disconnect the plug from the outlet. 2. If any abnormalities (such as damage or wear) are found on the power cable or plug, the power cable and plug must be replaced. Stop using the system immediately and contact your Canon Medical Systems service representative. Continuing to use the system may result in electric shock, fire, or interruption of power supply. 3. Do not use the system if the connection to the outlet is loose. 4. If an abnormal smell, abnormal noise, or smoke is noticed, immediately turn the main power switch on the power panel OFF and disconnect the plug from the power outlet. Continuing to use the system with such an abnormality may result in a fire etc. When using the system, ensure that there is enough space for access to the main power switch.

No. 2B771-141EN*Y 18

WARNING: 5. Do not allow this system or other equipment to come into

contact with the patient. If this system or other equipment is defective, the patient may receive an electric shock.

6. Do not connect any devices other than those specified by Canon Medical Systems to the USB connector or other connectors on the system. 7. Do not connect transducers other than those specified by Canon Medical Systems to the system. The use of transducers other than those specified may result in electric shock or fire. 8. Do not use a defective transducer. 9. Do not remove the covers or panels of the system. Doing so exposes high-voltage parts. 10. When in the patient environment, the operator must not touch any exposed connectors. In addition, if the system covers have been removed for some reason, the operator must be extremely careful not to touch any part where the voltage exceeds 25 VAC or 60 VDC and the patient at the same time. Doing so may result in an electric shock. 11. Connect the equipotential terminal (

) of this system

to the equipotential bus of the facility using an equipotential conductor. When this system is used close to a device that is applied directly to the patient heart (such as in a cardiac catheterization room, CCU, or ICU), voltage equalization with the device is required in order to prevent electric shock to the patient. 12. A functional ground terminal ( ) is used to connect a functional grounding wire between systems or between the system and the ground for functional purposes of the system (for example, to eliminate potential differences in the signal level between systems or to eliminate potential differences between the system and the ground). Do not use the functional ground terminal for protective grounding. Also, do not connect the functional ground terminal to a gas pipe or water pipe. Doing so may result in the failure of functional grounding or in a gas explosion. 13. Use a separate socket with an appropriate rated capacity for the supply of power to this system. 14. Do not connect this system to an outlet that shares a circuit breaker (or fuse) with an outlet to which a device such as a life-support system is connected. If this system malfunctions and generates an overcurrent, or if there is a current surge when the power is turned ON, the circuit breaker may trip (or the fuse may blow). 15. Do not connect the diagnostic ultrasound system to the same power outlet as another device. Doing so may cause the circuit breaker of the facility to trip, fuses to blow, or a fire or electric shock to occur.

No. 2B771-141EN*Y 19

WARNING: 16. Remove the ECG electrodes from the patient before using

devices such as electric scalpels, high-frequency therapy equipment, electrostimulators, or electric defibrillators. In addition, when using such devices, do not let ultrasound transducers, PCG microphones, or pulse wave sensors to come into contact with the patient. Doing so may result in the patient receiving a burn injury or an electric shock.

CAUTION: 1. To prevent electric shock, do not connect peripheral units

(such as a video printer or video recording unit) to an external outlet. Peripheral units should be connected inside the system. For the connection procedures, contact your Canon Medical Systems service representative.

2. If any abnormality of the system is found as a result of inspection, stop using the system and contact your Canon Medical Systems service representative for repair. 3. Do not spill or spray liquids such as water onto the system or peripheral units.

2.5

Chemical Hazard Observe the following instruction in order to protect patients and operators from inflammation or poisoning by chemical substances.

WARNING:

This product can expose you to chemicals including lead and lead compounds, which are known to the State of California to cause cancer, and phthalates, which are known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov.

No. 2B771-141EN*Y 20