ARIETTA 850 Instructions for Use Rev 5 March 2018

Thank you for purchasing the Hitachi, Ltd. ALOKA ARIETTA 850 Diagnostic Ultrasound System; we truly appreciate your business. IMPORTANT Before using the instrument, please read this manual and make sure you understand it. Be sure to keep this manual handy for future reference.

Please note that actual screen displays (including icons and design) may differ from the Diagnostic Ultrasound System screens reproduced in this manual. Some of the messages described in this manual may not be displayed by the Diagnostic Ultrasound System, depending on its configuration (including its options). For information regarding functions not described in this manual, refer to the separate “Acoustic Output Data”, “Basic Operations”, “Advanced Operations (1 to 3)” and “Measurements (1 to 3)”. The contents of this manual apply to both the ARIETTA 850 and the ARIETTA 850SE which are considered to be equivalent models. Any and all mentions of "ARIETTA 850" in this manual apply to both the ARIETTA 850 and the ARIETTA 850SE.

Trademarks and Registered Trademarks Microsoft, Windows, Microsoft Excel and Windows Media are registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. Adobe, Acrobat, and Reader are trademarks or registered trademarks of Adobe Systems Incorporated in the United States or other countries. The company name, product names, and logo of McAfee, in both English and Japanese, are trademarks or registered trademarks of McAfee, Inc. or its affiliated companies. Linux is a registered trademark of Linus Torvalds in Japan and other countries. VS-FlexGrid Pro copyright©1999-2000 Videosoft Corporation. This software is based in part on the work of the Independent JPEG Group. Real-time Tissue Elastography, Real-time Virtual Sonography, 4Dshading, HI REZ and HdTHI are registered trademarks in Japan of Hitachi, Ltd. Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners. SYNAPSE is a trademark of FUJIFILM MEDICAL SYSTEMS U.S.A., INC. OMNITRAX and VIRTUTRAX are trademarks of CIVCO. 4D LV-ANALYSIS©, 4D RV-FUNCTION©, and 4D MV-ASSESSMENT© are optional modules of TOMTEC-ARENA™. TOMTEC-ARENA™ is a registered trademark of TOMTEC IMAGING SYSTEMS GMBH in Germany and the United States of America. Other company names, product names and system names mentioned in the instruction manual of this instrument may be the trademarks or registered trademarks of their respective organizations. This document omits symbols such as ™ and ®. ©Hitachi, Ltd. 2016, 2018. All rights reserved.

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MN1-6227 rev.5

Precautions concerning the software incorporated with this instrument Regarding the software installed in this instrument, the following actions are prohibited. (1) Reselling, assigning, or transferring the software itself (2) Reverse engineering, reverse compiling, or reverse assembling (3) Modification, alteration or translation (4) Creating copies or duplicates (5) Leasing to third parties

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 Symbols Used in this Document The terms below are used as follows in this manual, to prevent hazards and injuries to operators and patients. The severity of a hazard and injury that can occur when failing to observe the displayed safety information is indicated in 4 levels: DANGER, WARNING, CAUTION, and NOTE. Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor injury or property damage. Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the equipment, and also to ensure that it is used efficiently.

The safety symbols have the meanings shown below.

This symbol means attention is required. This symbol indicates a prohibition. This symbol indicates a mandatory action.

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MN1-6227 rev.5

 About ALOKA ARIETTA 850 Diagnostic Ultrasound System This device is intended to be used by doctors and other qualified persons to perform tomography and hemodynamic diagnosis of blood flow in the human body. However, this device cannot be used to perform an eye ultrasound. The acoustic power from this device exceeds the upper ophthalmologic limit according to U.S. FDA standards. I)

Precautions concerning the use and management of this device 

Operations for diagnostic purposes are to be performed by doctors or other quality persons only.



Perform scans for the minimum length of time and at the lowest output needed for diagnosis.



Do not disassemble, repair, or modify the device or its optional equipment without the permission of this company. Repair work will be handled by personnel certified by this company. Please notify us when repair work is needed. NOTE: Disassembly means the use of tools to remove the casing or other parts of the device. NOTE: Modification means the attachment, to this device, of parts or devices other than those specified by

this company. Modification includes the replacement of the power cable. 

The device and any optional equipment will be installed (mounted and connected by using tools) by certified partners of this company. Please notify us when the device or optional equipment needs to be installed.



The device will be transported (moved via vehicle or ship, etc.) will be performed by an authorized representative of this company. Please notify us when the device needs to be transported.



Periodically clean and inspect the device. For details, see “Instructions for Use”.



If an abnormality occurs during the use of the device, immediately remove the probe from the patient and stop using the device. If the patient exhibits unusual or abnormal symptoms, immediately provide the appropriate medical treatment. Perform the appropriate measures for the device in accordance with “Instructions for Use”. If the abnormality is not described in “Instructions for Use”, please contact us.

II) Precautions concerning device installation This device is medical electrical equipment intended for use in hospitals, research institutions, and other similar facilities. Install this device as described below. 

Install the device in accordance with “Instructions for Use”.



Install the device in an environment that meets the conditions described in “Instructions for Use”.



Install the device in an environment that can maintain electromagnetic compatibility according to “Instructions for Use”. Electromagnetic compatibility (EMC) means that the device can maintain basic performance and safety within the relevant electromagnetic environment, without causing electromagnetic interference that cannot be tolerated by other devices in that environment.

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III) External dimensions and weight of the device

External dimensions

Width: 550 mm ±10%, Depth: 900 mm ±10% Height: 1220 mm ±10% to 1695 mm ±10%

Weight

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145 kg ±10% (main unit only), 163 kg ±10% (main unit and all optional equipment)

MN1-6227 rev.5

 Device classification of ALOKA ARIETTA 850 Diagnostic Ultrasound System  Protection against electric shock: Class I and ME equipment  Protection against electric shock (applied parts): Type BF applied part –

Probes and scanner Refer to the diagram below (or the probe or scanner diagrams) and table below for applied parts and parts handled as such. B

C

A

connector

D

connector

C

A

The above is an example of probes for surface or intraoperative use. Below are examples of body cavity probes. Parts handled as applied parts

Using a Probe

Applied part

Body surface

Ultrasonic irradiation area (D) Between A and B

100 cm

Intraoperative

Ultrasonic irradiation area (D) Between A and B

20 cm

Inside the body cavity Between A and C –

Length between B and C

Between A and C

–

ECG, PCG, Pulse Applied parts are regarded as such within a 2 m range from a physiological signal sensor (see drawing below). Example: ECG 2 meters ECG electrodes connector ECG patient lead

 Protection against electric shock (Defibrillation-proof applied parts): Not suitable  Protection against infiltration by water or particulate substances –

Probe applied part: IPX7 (rated for brief immersion in water)

–

Foot switch MP-2819: IPX7 (rated for brief immersion in water) MP-2345B: IPX8 (rated for continuous immersion in water)

–

Other Details: IPX0 (ordinary equipment)

 Suitability for use in an oxygen rich environment: Not suitable –

Method(s) of sterilization: Not suitable for sterilization/disinfection with medicinal solution, gas or radiation.

 Operation mode: Continuous operation

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MN1-6227 rev.5

Table of Contents 1

Precautions... 17 1-1 1-1-1

Warnings and Safety Information...19

1-1-2

Labels...22

1-2

Precautions Concerning Acoustic Power...27

1-3

Precautions Concerning the Probe...29

1-3-1

Handling Precautions...29

1-3-2

Cautions in Performing a Puncture Operation...31

1-4

Precautions for Use in Conjunction with Drugs...33

1-5

Precautions for Use With Other Medical Devices...34

1-6

Precautions for Maintaining Electromagnetic Compatibility...36

1-7

Precautions Concerning Power Plugs and Power Cables...38

1-8

Precautions Concerning Real-time Virtual Sonography...39

1-8-1

2

2-1

Intended Use...44

2-2

Operating principles...45

2-3

Specifications...47

2-3-1

Power Supply Conditions...51

2-3-2

Ambient Conditions...51

2-3-3

Device classifications...52

Part names...53

Setup Before Use... 59 3-1

MN1-6227 rev.5

Precautions for electromagnetic compatibility...41

Product Summary... 43

2-4

3

Safety Precautions...18

Installation and Moving...60

3-1-1

Shutting Down, and Disconnecting the Power Supply...60

3-1-2

Moving the Instrument...62

3-1-3

Installing the Instrument...67

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3-1-4

3-2

Installation Conditions...69

Connecting a Probe...70

3-2-1

Connecting an Independent Probe...72

3-2-2

Connecting a Probe with a Lock Lever...73

3-2-3

Disconnecting a Probe...74

3-2-4

Adjusting the positions of the cable hooks...76

3-3

Physiological Signal Cable Connection...80

3-4

Connecting to Other Connectors...82

3-4-1

Connecting to a USB Connector...82

3-4-2

Making Connections to the Equipotential Terminal...83

3-4-3

Connecting a Foot Switch (Option)...83

3-4-4

Connecting peripheral equipment...84

3-4-5

Safety Instructions for Connecting Network Devices...86

3-4-6

Safety Instructions for Robotic Surgery Unit...87

3-5

Inspections and Verifications Prior to Powering up...88

3-6

Powering Up...89

3-7

Inspections and Verifications After Powering up...89

3-7-1

3-8

Screen display...90

Default...93

3-8-1

Setting the hospital name...93

3-8-2

Configuring the DICOM communication settings...94

3-8-3

Date and time adjustment...96

3-9

Operation panel and monitor adjustment...97

3-9-1

Adjust the height of the operation panel...97

3-9-2

Rotating the operation panel...98

3-9-3

Adjusting the monitor height or orientation...99

3-9-4

Adjusting the brightness levels of the screen, operation panel, and touch panel . ... 101

3-10 3-10-1

Operating Procedures... 104

3-10-2

Cleaning... 105

3-10-3

Troubleshooting... 106

3-11

10 |

Gel warmer... 103

Alphanumeric keyboard... 107

3-11-1

Putting the alphanumeric keyboard out... 107

3-11-2

Putting the alphanumeric keyboard away... 108

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3-11-3

4

Operating procedures... 111 4-1

Examination Steps... 112

4-2

Entering Patient Data... 113

4-2-1

Screens for Entering Patient Data... 113

4-2-2

Entering Patient Data... 115

4-3

Switching Probes and Applications... 116

4-4

Adjusting Ultrasonic Output Power... 117

4-4-1

Ultrasonic Output Power Limit for Fetal Observation... 117

4-5

Adjusting Audio Volume... 119

4-6

Mode Display... 120

4-6-1

Displaying B Mode Images... 120

4-6-2

Displaying M Mode Images... 122

4-6-3

Displaying color Doppler images... 124

4-6-4

Displaying the PW waveform... 125

4-6-5

Displaying the CW Waveform... 127

4-7

Playing back cine memory images... 128

4-7-1

Using the trackball to search and scroll... 128

4-7-2

Using the [Freeze] rotary encoder to search and scroll... 128

4-7-3

Using the [Pointer] rotary encoder for searching and scrolling... 129

4-7-4

Continuous playback of tomographic images... 129

4-8

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Securing the alphanumeric keyboard... 109

Entering Comments... 131

4-8-1

Entering Text Using the Keyboard... 131

4-8-2

Entering Pointers... 133

4-8-3

Selecting and Entering Words... 134

4-8-4

Moving, Deleting, Replacing and Inserting Words... 135

4-9

Displaying Body Marks... 137

4-10

Making Measurements... 139

4-10-1

Distance Measurement: Dist... 140

4-10-2

Area and Circumference Measurements: Area-T... 141

4-10-3

Area and Circumference Measurements: Area-E... 142

4-10-4

Velocity Measurement: M.VEL... 143

4-10-5

Time Measurement: Time... 144

4-10-6

Blood flow velocity measurement: D.VEL1... 145

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4-10-7

Blood flow velocity measurement: D.VEL2... 146

4-10-8

Pulsatility Index Measurement: PI... 147

4-11

Printing and Saving Images... 150

4-11-1

Printing Images... 150

4-11-2

Saving a Still Image... 150

4-11-3

Saving Moving Images... 151

4-11-4

Saving moving images for a preset time interval or set number of heartbeats: Post ECG/Post Time... 152

4-11-5

Saving moving images for a set time interval or number of heartbeats prior to an event: PreECG/PreTime... 152

4-11-6

Saving moving images anytime: Manual... 153

4-11-7

Saving Moving Images in Raw Format: Manual Raw Store... 154

4-11-8

Saving a Moving Image at a Specified Range after Freezing... 155

4-12

5

Reading the Instruction Manual... 156

4-12-1

Viewing Instruction Manuals on the Instrument Screen... 157

4-12-2

Viewing Instruction Manuals Stored on CD-ROM... 159

4-13

Procedures After Instrument Use... 160

4-14

Inspection After Instrument Use... 161

4-15

Storage... 162

Maintenance... 163 5-1

Cleaning and Disinfection... 164

5-1-1

Using Approved Disinfectants... 166

5-1-2

Frequency of Cleaning and Disinfection... 168

5-1-3

Cleaning and Disinfecting Device Exterior... 169

5-1-4

Cleaning the Filters... 170

5-1-5

Cleaning and Disinfecting Viewing Monitor Cover... 171

5-1-6

Cleaning and Disinfecting the Viewing Monitor (the OLED Surface and LCD Surface)... 172

5-1-7

Cleaning and Disinfecting the Operation Panel and Alphanumeric Keyboard... ... 173

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5-1-8

Cleaning and Disinfecting the Touch Panel... 174

5-1-9

Cleaning and Disinfecting the Trackball... 175

5-1-10

Cleaning and Disinfecting the Power Plug... 178

5-1-11

Cleaning and Disinfecting the Power Cable... 179

5-1-12

Cleaning and Disinfecting the Area of the Casters That are in Contact With the

MN1-6227 rev.5

Ground... 180 5-1-13

Cleaning and Disinfecting the Probe Holder... 181

5-1-14

Cleaning and Disinfecting the Transvaginal/Transrectal Probe Holder... 183

5-1-15

Cleaning and Disinfecting the Transvaginal/Transrectal Probe Holder Adapter . . . ... 186

5-1-16

Cleaning, Disinfecting and Sterilizing Probes... 188

5-1-17

Cleaning and Disinfecting the RVS Sensor... 188

5-1-18

Cleaning and Disinfecting Electrocardiogram Cable (ECG Cable, etc.)... 188

5-1-19

Cleaning and Disinfecting the Foot Switch... 189

5-1-20

Cleaning Peripheral Equipment... 190

5-2

6

7

The Need for Regular Maintenance Inspections... 191

5-2-1

Daily inspection: For a Long Service Life... 192

5-2-2

Measurement Accuracy Inspection... 193

5-2-3

Measurement Accuracy Inspection Record Table... 198

5-2-4

Safety Inspection... 201

5-2-5

Diagnostic Ultrasound System Safety Inspection Data Sheet... 205

5-3

Troubleshooting... 208

5-4

Repair, Readjustment and Product Disposal... 210

Product Configuration... 211 6-1

Standard Configuration... 212

6-2

Options... 213

6-3

Probes... 216

6-3-1

Probe Functions: Basic Functions... 220

6-3-2

Probe Functions: Optional Functions... 223

6-3-3

Measurement Scope... 225

Safety Guidelines... 227 7-1

Guidelines for Electromagnetic Compatibility... 228

7-1-1

Guidance and Directive Concerning Electromagnetic Emissions... 228

7-1-2

Essential performance... 229

7-1-3

Guidance and Declaration Directive Concerning Electromagnetic Immunity . 230

7-1-4

Table Guidance and Declaration Directive Concerning Electromagnetic Immunity (conducted RF and emitted RF)... 231

7-1-5

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Recommended separation distance between cellular and mobile RF

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communication instruments and the instrument... 232

8

9

7-2

Electrostatic Discharge (ESD) Guidelines... 233

7-3

Ultrasound Output Safety Information... 234

7-3-1

Acoustic Power Index... 234

7-3-2

Ultrasound Wave, Interaction between Vital Tissues... 236

7-3-3

Derivation and Meaning of MI/TI... 239

7-3-4

Setting Conditions Influencing Device Output... 242

7-3-5

ALARA: As Low As Reasonably Achievable Recommended... 244

7-3-6

Default Settings... 245

7-3-7

Acoustic Power Upper Limit... 245

7-3-8

Protocol for Calculating the Measurement Uncertainties... 246

7-3-9

References... 256

Messages... 257 8-1

Messages About Image Display... 258

8-2

Messages about patient data entry... 261

8-3

Messages about saving display images... 266

8-4

Messages about searching for, playing and transferring saved images . . 268

8-5

Messages about the recorder... 277

8-6

Messages about the presets... 278

8-7

Messages About Importing CSV Files... 282

8-8

Other Messages... 284

License Information... 289 9-1

Warning regarding the software used for this instrument... 290

9-2

Microsoft Software License Terms... 291

9-2-1

Notes on Microsoft Software License Terms... 291

9-2-2

WINDOWS EMBEDDED 8.1 INDUSTRY PRO... 292

9-3 9-3-1

9-4 9-4-1

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McAfee Embedded Control... 302 Software License Agreement... 303

Oracle Java SE... 305 Software End User License Agreement... 305

MN1-6227 rev.5

9-5

Free Software License Information... 306

9-6

Free Software Module User License Agreement... 311

9-6-1

GNU GENERAL PUBLIC LICENSE Version 2.0... 311

9-6-2

GNU Library General Public License version 2.0... 318

9-6-3

GNU LESSER GENERAL PUBLIC LICENSE Version 2.1... 329

9-6-4

GNU GENERAL PUBLIC LICENSE Version 3, 29 June 2007... 339

9-6-5

Apache License Version 2.0... 353

9-6-6

The BSD 3-Clause License... 358

9-6-7

The BSD 2-Clause License... 359

9-6-8

The MIT License... 360

9-6-9

Mozilla Public License 1.1... 361

9-6-10

Common Development and Distribution License 1.0... 370

9-6-11

FreeType Project License... 377

9-6-12

Libtiff Software License... 382

9-7 9-7-1

MN1-6227 rev.5

DCMTK... 383 Copyright of DCMTK... 384

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1 Precautions

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Precautions

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Safety Precautions

1-1

Safety Precautions The terms below are used as follows in this manual, to prevent hazards and injuries to operators and patients. The severity of a hazard and injury that can occur when failing to observe the displayed safety information is indicated in 4 levels: DANGER, WARNING, CAUTION, and NOTE. Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor injury or property damage. Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the equipment, and also to ensure that it is used efficiently.

The safety symbols have the meanings shown below.

This symbol means attention is required. This symbol indicates a prohibition. This symbol indicates a mandatory action.

18 | Precautions

MN1-6227 rev.5

Safety Precautions

1-1-1

Warnings and Safety Information

DO NOT use this instrument in a flammable atmosphere. Use of this instrument in a flammable atmosphere may cause an explosion.

DO NOT attempt to repair the instrument. Do not disassemble. Do not modify (the power cable is must not be replaced). *1, *2 Electric shocks and other accidents could result. For details regarding instrument repair, please contact our office. Do not use on patients who may have an allergic reaction to latex products. Use of a rubber cover when examining such patients could result in an anaphylactic shock. Ask the patient about allergy history beforehand. Use probes that are cleaned, disinfected, and sterilized with each examination. Wear medical gloves during examination, and wash your hands as standard practice once the examination is complete. Otherwise, there is a risk of infection to the examiner and patient. Dispose of probes used for patients with Creutzfeldt-Jakob disease. Otherwise, there is a risk of infection to the examiner and patient. Our ultrasound probe is not compatible with any disinfection/sterilization method for Creutzfeldt-Jakob disease. *1. *2.

Disassembly means the use of tools to remove the casing or other parts. Modification means attachment of parts or devices to this instrument other than those specified by the manufacturer. Replacement of a power cable counts as a modification.

The service life of the instrument is seven years. This is the service life you can expect when the instrument is used, maintained and inspected under prescribed operating conditions and when components that need regular replacement are replaced as required. For details on recommended maintenance and inspections, refer to “The Need For Regular Maintenance Inspections” in this manual. For details on components that need regular replacement, please contact our office. Regularly perform maintenance inspection and safety inspection of the instrument and probes. With prolonged use, some parts of this instrument may deteriorate, causing it to fall below full performance or causing smoke emission and fire. If anything unusual occurs, immediately stop using it and contact our office. Do not connect devices and probes other than those specified in this manual to the instrument. Use with unapproved devices can result in an electric shock, burns, or other injuries to the patient or examiner, and damage to this instrument. All non-medical devices connected to the instrument must comply with the relevant IEC or ISO Standards (e.g.: IEC 60950-1 for information technology devices). Furthermore, the entire configured ME system must comply with clause 16 of the Medical Electrical Equipment Standard (IEC 60601-1: Ed3). If there are any applicable ordinances, they should be prioritized. For more details, please contact our office.

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Precautions

| 19

Safety Precautions

Do not install this instrument or optional equipment without our approval. Do not transport. *1, *2 Electric shocks and other accidents could result. Contact our office in the event you wish to transport or install this instrument and any optional equipment. *1.

Installation means the use of tools for mounting and connection.

*2.

Transportation means the movement of this product on a vehicle, ship, etc.

Install the instrument in the following locations: • A flat surface of adequate strength not prone to vibration. • An area where there is no water or other fluid, no large amounts of salt or sulfur, and no direct sunlight. Injuries or burns etc. to the patient or the examiner could result. Adjust the position and orientation of the monitor, keeping a sufficient distance between the instrument and the peripheral equipment, walls and people. Do not knock the monitor against the touch panel, USB connected medium, cable hook, probe, probe holder, operation panel, or other parts. Route the probe cables so that they do not become entangled with the monitor, monitor arm and the instrument rear handle. Contact with the monitor may result in injury or in damage to the surrounding equipment, the walls, the probe, the instrument, the monitor or the touch panel. Warn doctors, patients, and others in the area before adjusting the position and orientation of the monitor. Should the monitor break and its internal fluid come into contact with the skin, wipe it away and wash the skin in running water for at least 15 minutes. To be on the safe side, consult a doctor. If it gets in someone's eyes, rinse them in running water for at least 15 minutes, and be sure to consult a doctor. If the monitor is damaged, stop using the instrument immediately and contact our office. Do not block the ventilation holes. The temperature inside the instrument will rise, leading to fire or breakdown. Do not spill water or other liquids on the body of the instrument. The instrument is not protected against the entry of liquids. Using the instrument with water on it can cause electric shock and short-circuiting. Should liquid spill on the instrument, please contact our office. The instrument must be dry when used. Avoid rapid temperature changes which can cause condensation. Using the instrument when condensation or water drops are present could result in malfunction, electric shock or short-circuits. If you observe anything abnormal in the instrument, probes, peripherals or options, turn the power off immediately, and stop using the instrument. Such situations can result in injury to the patient or operator, or other unexpected accidents. Check for messages, temperature, damage and other aspects of instrument status, then contact our office. If anything unusual occurs in the instrument or the patient when this instrument is used, remove the probe from the patient immediately and stop using the instrument. If the patient condition is abnormal, take appropriate medical action. When using this instrument, watch to make sure that it is functioning normally, and that the patient is not abnormally affected.

20 | Precautions

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