SSD-α10 Instruction Manual Safety Instruction volume 1-2 rev 26 ver 8.0.2

ProSound logo is registered mark of Hitachi Aloka Medical, Ltd. in Japan and other countries. Copyright©Hitachi Aloka Medical, Ltd. All rights reserved. Microsoft and Windows Media player is registered trademark of Microsoft Corporations in United States and/or other countries. All brand name and product name are trademarks or registered trademarks of their respective companies. In this manual, ® and ™ are omitted. VS-FlexGrid Pro copyright©1999-2000 Videosoft Corporation. Portions of this software are based in part on the work of the Independent JPEG Group.

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MN1-5205 rev.26

INTRODUCTION

Introduction This is an instruction manual for the model SSD-α10, an ultrasound diagnostic instrument. Read the manual carefully before using the instrument. Take special note of the items in Chapter 1, "Safety Precautions.". Keep this manual securely for future reference.

Symbols Used in this Document The following items are important in preventing harm or injury to equipment operator or patient. There are four levels of harm/damage that can be caused by ignoring instructions or displays and using the equipment incorrectly: "Danger," "Warning," "Caution," and "Note." These types are indicated by the following symbols. Indicates an imminently hazardous situation that will result in the death of or serious injury to the equipment operator. Indicates a hazardous situation that could result in death or serious injury. Indicates a hazardous situation that may result in slight or moderate injury, or property damage. Indicates a request concerning an item that must be observed in order to prevent damage or deterioration to the equipment and also to ensure effective use.

Cautions use the following graphics

This mark indicates and alert, additional information.

This mark indicates that the action is not allowed.

This mark indicates that the action is required.

Conventions used in this manual. NOTE: Notes containing additional information. IMPORTANT: Information that is considered especially important.

改 訂

Input, output and screen-messages are presented in the following font: message. Menus and switches are written as Menu. Submenus are indicated by the use of angle brackets: Menu > sub-menu > sub-menu.

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INTRODUCTION

About the model “SSD-α10” The SSD-α10 is intended to be used by doctors and other qualified personnel in fracture diagnostics and hemodynamic diagnostics. However, this equipment is not designed to be used in ophthalmic ultrasound diagnosis, as its sound intensity is not compliant with ophthalmic restrictions established by the FDA. Only physicians and other qualified personnel should operate this equipment for diagnostic purposes. Read section 1-1 of the Safety Instruction. 1)

PRECAUTIONS Concerning the Use/Management of the SSD-α10 •

Do not disassemble, repair or remodel this equipment or optional features without our consent. NOTE: Disassemble is removing the parts or options from the equipment using

tools. NOTE: Remodel is installing or connecting the unspecified parts or equipment,

including replacement of power cord. •

Assemble of the equipment or optional accessories shall be performed by a third party certified by us. Please contact one of our offices listed on back cover. NOTE: Assemble is installing and connecting the parts or optional accessories on

the main equipment using tools.

2)

•

Transporting this equipment (via automobile/ship) shall be performed by a third party certified by the manufacturer. Please contact one of our offices listed on back cover.

•

Please conduct routine cleaning and inspection of the equipment. Refer to Chapter 5 of the Safety Instruction for details. .

•

Ensure that the output level of the scan conforms to the required duration of diagnosis.

•

If any malfunction or abnormality is discovered during operation of the equipment, remove the probe from the patient immediately and discontinue use. If any abnormality is observed in the patient, provide proper care as quickly as possible. Refer to Chapter 4 of the Safety Instructions for more information on dealing with the equipment appropriately. If the malfunction is not listed in Chapter 4 of the Safety Instructions, contact one of our offices listed on back cover.

PRECAUTIONS for the SSD-α10 Installation This equipment is a medical electrical device that is intended for use in hospitals, and research facilities. The equipment should be installed in accordance with the following guidelines.

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•

Install in accordance with Chapter 3 of the Safety Instructions. .

•

Install in an environment that conforms to the operating environments indicated in section 2-2-2 of the Safety Instructions.

•

Install in an environment that ensures electromagnetic compatibility, in accordance with section 1-2-6 of the Safety Instructions, "Precautions Concerning the Maintenance of Electromagnetic Compatibility," and Item 1-3, "Guidelines for Electromagnetic compatibility." NOTE: The electromagnetic compatibility (EMC) is the ability of device to function

satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance to anything in that environment.

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MN1-5205 rev.26

INTRODUCTION

Classification of model “SSD-α10” • Protection against electric shock (ME equipment): class I • ME equipment • Protection Against Electric Shock (Applied Parts): Type BF Applied Parts –

Probe/scanner applied parts and parts treated as applied parts: Refer to the following diagram (Probe/Scanner Pattern Diagram) and table.

Figure: Probe/Scanner Pattern Diagram Above illustrates a surface/intraoperative probe. Below shows a coelomic probe. B

C

A

connector

D

connector

C

A

Applicable part of body

Applied part

parts treated as applied parts

B - C length

surface of body

Ultrasonic irradiation area (D)

A to B

100 cm

Intraoperative

Ultrasonic irradiation area (D)

A to B

20 cm

Endocavity

A to C

A to C

N/A

–

Physiological signal applied part: ECG electrodes Part treated as applied part: 2m from the ECG electrode of the ECG patient cable (consult following diagram) 2 meters ECG electrodes

connector ECG patient lead

• Protection against electric shock (Defibrillation-proof applied parts): Not suitable • Protection against harmful ingress of water or particulate matter –

equipment: IPX0 (Ordinary equipment)

–

Probe applied part: IPX7 (Watertight 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. • Mode of operation: Continuous operation

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CONTENTS 1 Safety Precautions 1-1

Purpose of Use ... 1-1

1-2

Precautions for Use ... 1-2 1-2-1 1-2-2 1-2-3 1-2-4 1-2-5 1-2-6

1-3

Electromagnetic compatibility ... 1-17 1-3-1 1-3-2 1-3-3 1-3-4 1-3-5

1-4

Warnings and Safety Notice ... 1-3 Labels on the equipment ... 1-6 Precautions concerning acoustic power ... 1-13 Precautions for Use in Conjunction with Drugs ... 1-14 Precautions for Use in Conjunction with Other Medical Devices... 1-15 Guideline for Electromagnetic Compatibility... 1-16 Guidance and manufacturer’s declaration –electromagnetic emissions ... 1-17 Essential performance... 1-18 Guidance and manufacturer’s declaration – electromagnetic immunity ... 1-19 Guidance and manufacturer’s declaration – electromagnetic immunity ... 1-20 Recommended separation distances between portable and mobile RF communications equipment and the SSD-α10 ...1-21

Electrostatic Discharge (ESD) Guidelines ... 1-22

2 Specification and Component Names 2-1

Principle of Operation ... 2-1

2-2

Specifications ... 2-3 2-2-1 2-2-2 2-2-3

2-3

Power Requirements ... 2-7 Environmental Conditions ... 2-7 Classification of model “SSD-α10” ... 2-8

Name of Each Parts ... 2-9 2-3-1 2-3-2

Name of Each Parts ... 2-9 Operation panel ... 2-15

3 Preparation for Use

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3-1

Installing the equipment ... 3-1

3-2

Connecting the Peripheral Instrument ... 3-3 3-2-1 3-2-2 3-2-3

3-3

Connecting a Probe to the Instrument... 3-4 Connect the Physiological Signal Connector ... 3-6 Connecting with Other Instrument ... 3-9

Moving the equipment ... 3-11 3-3-1 3-3-2

Isolate from the supply main ... 3-11 Move the equipment ... 3-11

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3-4

Storing the Instrument ... 3-15

3-5

Inspection Before Using ... 3-16 3-5-1 3-5-2

3-6

Screen Display ... 3-18 3-6-1 3-6-2 3-6-3

3-7

Character Display ... 3-18 Graphic Display ... 3-20 Color display... 3-21

Adjusting the Operation Panel ... 3-22 3-7-1 3-7-2

3-8

External Inspection ... 3-16 Operation Check ... 3-17

Adjust the Height of the Operation Panel ... 3-22 Adjust the position of the operation panel ... 3-23

Adjusting the Monitor ... 3-24 3-8-1 3-8-2

Adjust the Angle and Position of the Monitor ... 3-24 Adjust the Brightness of the Monitor ... 3-27

4 Troubleshooting 4-1

Messages ... 4-1 4-1-1 4-1-2

4-2

Message List ... 4-2 Assistant Messages ... 4-11

Other troubles ... 4-13 4-2-1

Image Display and Image Degradation ... 4-13

5 Maintenance 5-1

After Using the Instrument ... 5-1 5-1-1

5-2

Cleaning ... 5-3 5-2-1 5-2-2 5-2-3

5-3

State of the Instrument and Accessories... 5-2 Clean the Instrument ... 5-4 Cleaning the trackball ... 5-5 Cleaning the air filter ... 5-6

Maintenance ... 5-7 5-3-1 5-3-2 5-3-3

Daily check: For Using the Instrument for a Long Period ... 5-8 Checking the Measurement Accuracy... 5-9 Safety Inspection... 5-16

6 Accessories and options 6-1

Standard composition ... 6-1

6-2

Options ... 6-2

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7 Probes 7-1

Caution in the Handling of Probes ... 7-1 7-1-1 7-1-2

7-2

Probe specifications ... 7-7 7-2-1 7-2-2 7-2-3 7-2-4 7-2-5 7-2-6 7-2-7 7-2-8 7-2-9 7-2-10

7-3

Caution about Handling of Probes ... 7-1 Cautions about Cleaning and Storage ... 7-5 Convex Sector Probes ... 7-9 Phased Array Sector Probe... 7-12 Linear Probes ... 7-15 Combination Probes... 7-17 3D Probes ... 7-18 Mechanical Radial Probe ... 7-19 Mechanical Annular Array Sector Probe ... 7-20 Independent probe ... 7-20 Ultrasonic Gastrovideo Scope ... 7-21 Ultrasonic Bronchofiber Videoscope ... 7-22

Clinical Measurement Range ... 7-23

8 Acoustic Output Safety Information 8-1

Acoustic output index ... 8-1

8-2

Interaction between ultrasound and tissues ... 8-3 8-2-1

8-3

Possible Biological Effects ... 8-4

Derivation and Meaning of MI / TI ... 8-6 8-3-1 8-3-2

Mechanical Index (MI) ... 8-6 Thermal Index (TI)... 8-7

8-4

Setting condition influencing device output ... 8-9

8-5

Recommendation on ALARA principle ... 8-11

8-6

Default Setting ... 8-12

8-7

Acoustic output limits ... 8-12

8-8

Measurement uncertainties ... 8-13 8-8-1 8-8-2

8-9

Protocol for calculating the measurement uncertainties... 8-13 Results of measurement uncertainties ... 8-15

References ... 8-22

9 Acoustic Output Tables

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9-1

Acoustic power measurement value ... 9-1

9-2

Display accuracy of MI/TI ... 9-2

9-3

Acoustic Output Tables ... 9-2 9-3-1 9-3-2 9-3-3

Convex Sector Probe ... 9-4 Phased Array Sector Probe... 9-82 Linear Probe ... 9-160

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MN1-5205 rev.26

9-3-4 9-3-5 9-3-6 9-3-7 9-3-8 9-3-9 9-3-10

Combination Probe... 9-232 3D Probe ... 9-244 Mechanical Radial Probe ... 9-262 Mechanical Annular Array Probe... 9-265 Independent Probe... 9-267 Ultrasonic Gastrovideo Scope ... 9-269 Ultrasonic Bronchofiber videoscope ... 9-317

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1 Safety Precautions 1-1 Purpose of Use

1

Safety Precautions

1-1

Purpose of Use In the ultrasound diagnostic equipment, ultrasound images are produced as follows; Ultrasound wave pulses released from transducer are reflected from the internal body system. Reflected waves are transmitted the transducer, and ultrasound images are produced with the reflected image on the monitor. You can distinguish internal body system because the acoustic impedances vary among the internal organs. Ultrasound images are used for various diagnoses of the internal body system. This equipment SSD-α10 is intended to be used by doctors and other qualified persons for performing slice diagnoses and blood circulation diagnoses in the following parts of the human body. • Thorax • Abdomen • Perineum and pelvis • Lower limbs • Back • Upper limbs • Head • Neck Do not use it for any applications other than those stated above.

Do not use this equipment for performing ultrasound diagnosis of the eyes. The acoustic power from this equipment exceeds the upper ophthalmological limit indicated in the U.S. FDA standards.

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Do not use it for any application that is not covered in the instruction manual of the probe. There is a risk of injuries or burns of the patient or oprator. There is a risk of electrical shock, breakdown or other accidents.

2012.3.14 MS 技 MN1-5205 rev.26 アロカ

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1 Safety Precautions 1-2 Precautions for Use

1-2

Precautions for Use Before using this equipment, please read this manual. Especially be sure to read "1. Safety Precautions". Keep this manual securely for future reference. The following items are important in preventing harm or injury to the operator of the instrument and the patient. There are 4 levels of harm that can be caused by ignoring instructions or displays and using the instrument incorrectly: "Danger," "Warning," "Caution," and "Note. Indicates an imminently hazardous situation which, if not avoided, will result in the death or serious injury of the operator of the equipment. Indicates a hazardous situation which, if not avoided, may result in death or serious injury. Indicates a hazardous situation which, if not avoided, may result in slight or moderate injury, or property damage. Indicates a request concerning an item that must be observed in order to prevent damage or deterioration to instruments and also to ensure effective use.

These types are indicated by the following symbols.

This symbol means the corresponding item is "alerted."

This symbol means the corresponding item is "prohibited."

This symbol means the corresponding item is required.

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MN1-5205 rev.26

1 Safety Precautions 1-2 Precautions for Use

1-2-1

Warnings and Safety Notice

• Do not use this instrument in a flammable atmosphere. This equipment is not suitable for use in a flammable environment. It could cause an explosion.

• Do not disassemble, repair or remodel the equipment or optional features without our consent. Electric shock or other accidents could result. Please contact one of our offices listed on back cover. • Clean, disinfect and sterilze the probes as described in their documentation, before using them. • Wear medical gloves during inspection, and wash your hands after inspection. • Destroy the probes used on patients with Creutzfeld-Jacob disease patients. At present, there are no known methods available to properly clean and sterilize probes exposed to Creutzfeld-Jacob disease. There is a risk of infection of the patient and the examiner.

• If anything unusual occurs when this instrument is used, remove the probe from the patient immediately, and stop using the instrument. If the patient’s condition is abnormal, provide appropriate medical treatment. When using this instrument, observe that it is functioning normally, and that the patient is not abnormally affected. • DO NOT connect any probes or options to the SSD-α10 which is not specified in this manual. There is a risk of injuries or burns of the patient or operator. There is a risk of electrical shock, breakdown or other accidents. • DO NOT assemble or transport the equipment or its options via automobile or ship. Electric shock or other accidents could result. For assembling or transporting the equipment and its options, please contact one of our offices listed on back cover.

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1 Safety Precautions 1-2 Precautions for Use

Place instrument in the following location. • Place the instrument on a flat horizontal surface with sufficient stability and minimal vibrations. • DO NOT place the instrument on a precarious or uneven surface. • Avoid locations where the unit will be exposed to water, other liquids, salt or sulfur vapors, and keep out of direct sunlight. These locations may cause injuries such as burns to the patient or examiner. • Scan for the minimum length of time necessary for the diagnosis, and at the lowest suitable output. There is the possibility that the patient’s internal tissues could be affected. • Hold a probe tightly especially when using ultrasound gel store the unused probe in the probe holder. Otherwise, the probe may slip out of your hands and hit a patient or a examiner. • Coat the probe with an ultrasound medium before using. • When the probe is not in use even during an examination, freeze the image. Use of an ultrasonic beam into the air without coating the probe with an ultrasound medium, may cause surface temperature to rise. It could cause burns to the patient or examiner. • DO NOT touch the exposed sockets of the probe’s physiological signal cable connectors, or USB connector sockets. • DO NOT touch to the patient with parts of other than applied parts and parts treated as such. Doing so may cause electric shock or short circuitis. • Always use the instrument in a dry environment. Avoid rapid temperature change which may cause condensation. Using the instrument where condensation occurs or is spilled liquid, can cause electric shock or short-circuiting. Let the instrument stand for a while in a newly installed location in order for it to become acclimated to the environment before switching it ON. • DO NOT cover the vent. The temperature get hot, there is a risk of short-circuitting or other accidents. • Perform regular maintenance and inspection as indicated in this manual. Components of the equipment may deteriorate due to years of use. There is a risk for degrading its performance, braking down, emitting smoke or ignition. If you notice any problems, please contact one of our offices listed on back cover.

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MN1-5205 rev.26

1 Safety Precautions 1-2 Precautions for Use

Safety precautions about Power Plug and Cable

Use the power cable provided, and plug it directly into the wall receptacle (hospital grade). Using the cables or adapters to extend or branch the power connection may cause a short circuit, ground leakage or fire. • DO NOT damage, modify or sever the power cable. • DO NOT twist, bundle, forcibly bend, pull, or place heavy objects on the cable. Damaging the power cable may cause electric shock or short circuits. Should you discover deformations or abnormalities in the power cable or plug, stop using the equipment immediately. Using the equipment with damaged cable or plug may cause a loose connection or fire. Please contact one of our offices listed on back cover for servicing. Routinely disconnect the power cable plug from the outlet for washing. Use a dry cloth to wipe off any dust or moisture that accumulates on the power cable plug. Failure to do so may cause electric shock or short-circuits. For extended periods of disuse, disconnect the power plug from the outlet. Turning the power switch OFF does not completely shut off power to the equipment.

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1-5

1 Safety Precautions 1-2 Precautions for Use

1-2-2

Labels on the equipment Many marks are used in this equipment. NOTE: Refer to probe documentation for more information on probe labels.

Labels that have a combination

and

(mainly connector sockets) includes following

safety caution;

DO NOT touch the connector pins. There is risk of deterioration and failure of parts sensitive to static electricity. For details, See “Electrostatic Discharge (ESD) Guidelines” on page 1-22.

The following label indicates the risk of pinching in spaces or openings. Symbols are located in various places to indicate the relevant risks at that site.

Be careful of catching your fingers. There is a risk of injury of your hands or fingers.

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MN1-5205 rev.26

1 Safety Precautions 1-2 Precautions for Use

Labels on front side

Front panel

(6)

(8) (1)

(4)

(7)

(2)

(3) (5)

:Power switch :a probe connector socket and socket number (1 to 4)

(1)

:Type BF applied part

(2)

:Lock release pedal

(3)

:Lock pedal

(4)

:the Foot switch connection socket

IPX8 (5)

:Labels on the Foot switch : protented against the effects of continuous immersion in water : USB connector socket

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1 Safety Precautions 1-2 Precautions for Use

(6)

Follow the instruction manual to adjust the height of the operation panel and to move the instrument. Gripping the probe holders could result in braking the probe holders.

(7)

Follow the instruction manual to connect the USB flash memory.USB connector socket or USB flash memory could failure.

(8)

Follow the instruction manual to move the instrument.If the instrument lifted using operation panel, there is the possibility braking the operation panel.

RELATED LINKS: Move the equipment → p.3-11 Adjusting the Operation Panel → p.3-22 Connecting with Other Instrument → p.3-9

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MN1-5205 rev.26

1 Safety Precautions 1-2 Precautions for Use

Labels on Back side

(1) (2)

(3) (4)

(1)

:United State of America only.

(2)

:How to fix the monitor arm To fix the monitor arm, push the stopper. To move the monitor arm, pick up the stopper.

(3)

: It lists the model name, type refernece, and the manufacturer information.

(4)

:the potential equalization terminal, consult intstruction manual for use.

RELATED LINKS: Connecting with Other Instrument → p.3-9

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1 Safety Precautions 1-2 Precautions for Use

Labels on Left side

(1) (2)

(4) (3)

(1)

:How to move the instrument (rear casters)

Right pedal is rock pedal. When fixing the rear wheel, step the lock pedal down. Left pedal is swing lock pedal. When moving the instrument, step the swing lock pedal down. To move casters, step both the lock petal and swing petal down. Consult the instrument manual for use. (2)

Follow the instruction manual tomove the instrumentWhen the instrument is lifted to negotiate steps etc., there is the possibility that the instrument falls over.

(3)

:United State of America only.

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1 Safety Precautions 1-2 Precautions for Use

(4)

It lists the model name, type refernece, and the manufacturer information. 2011

This instrument complies with Directive 93/42/EEC relating to Medical Device. Date of manufacture. Number under the mark means the manufacturing year. Do not dispose the instrument as general waste.

2'8

Comply with a local regulations. Manufacturer

Each marks on label (4) means following;

Safety Warning sign.

Use the power cable provided, and plug it directly into the wall receptacle (hospital Dangerous grade). Voltage There is the risk of short circuiting or ground leakage.

Explosion

Do not use this instrument in a flammable atmosphere.

Scan for the minimum length of time necessary for the diagnosis, and at the lowest CAUTION suitable output. Acoustic There is the risk of that the patient’s internal tissues could be affected. Power

Be careful of catching your fingers. CAUTION There is a risk of injury of your hands or fingers. pinch

改 訂

Do not disassemble, repair (including replacement of power cord) or remodel this No instrument. Modification Electric shocks and other accidents could result. For sevice, please contact one of our offices listed on back cover.

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