prosound -α 7 Instruction Manual Safety Instruction Volume 1 of 2 rev 10

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. Real-time Tissue Elastography is a registered trademark of Hitachi Medical Corporation.

MN1-5368 rev.10

Introduction

Introduction This is an instruction manual for model ProSound α7, 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/displays or 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.

Contents of cautions shows 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.

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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3

Introduction

About the model “ProSound α7” The ProSound α7 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 ProSound α7 •

Do not disassemble, repair or remodel this equipment or optional features without our consent. NOTE: Disassemble means to remove the parts or options from the equipment

using tools. NOTE: Remodel means to install or connect unauthorized parts or equipment

including the power cord. •

Assembly of the equipment or optional accessories shall be performed by our third party certified. Please contact one of our offices listed on back cover. NOTE: Assemble means to install or connect parts or optional accessories in/to the

device 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 Instruction manual, contact one of our offices listed on back cover.

PRECAUTIONS for the ProSound α7 Installation This equipment is a electrical medical device that intended for use in hospitals and research facilities. The device should be installed in accordance with the following guidelines. •

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 Instruction manual.

•

Install in an environment that ensures electromagnetic compatibility, in accordance with section 1-2-6 of the Safety Instruction manual, "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.

4

MN1-5368 rev.10

Introduction

Classification of ProSound α7 • 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 Precaution 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 ... 1-15 1-3-1 1-3-2 1-3-3 1-3-4 1-3-5

1-4

Warnings and Safety Notice ... 1-3 Labels... 1-6 Precautions concerning acoustic power ... 1-11 Precautions for Use in Conjunction with Drugs ... 1-12 Precautions for Use in Conjunction with Other Medical Devices... 1-13 Guideline for Electromagnetic Compatibility... 1-14 Guidance and manufacturer’s declaration –electromagnetic emissions ... 1-15 Essential performance... 1-16 Guidance and manufacturer’s declaration – electromagnetic immunity ... 1-17 Guidance and manufacturer’s declaration – electromagnetic immunity ... 1-18 Recommended separation distances between portable and mobile RF communications equipment and the ProSound α7 ...1-19

Electrostatic Discharge (ESD) Guidelines ... 1-20

2 Specification and Parts Name 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 ... 2-6 Environmental Conditions ... 2-6 Classification of ProSound α7 ... 2-7

Name of Each Parts ... 2-8 2-3-1 2-3-2

Name of Each Part ... 2-8 Operation Panel ... 2-12

3 Preparations for Use 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

Moving the equipment ... 3-10 3-3-1 3-3-2

3-4

6

Connecting a Probe to the Instrument... 3-4 Connect the Physiological Signal Connector ... 3-6 Connecting with Other Instrument ... 3-8 Isolate from the supply main ... 3-10 Moving the Instrument ... 3-10

Storing the Instrument ... 3-13

MN1-5368 rev.10

3-5

Inspection Before Using ... 3-14 3-5-1 3-5-2

3-6

Screen Display ... 3-16 3-6-1 3-6-2 3-6-3

3-7

Character Display ... 3-16 Graphic Display ... 3-17 Color display... 3-18

Adjusting the Operation Panel ... 3-19 3-7-1 3-7-2 3-7-3 3-7-4

3-8

External Inspection ... 3-14 Operation Check ... 3-15

Adjust the Height of the Operation Panel ... 3-19 Adjust the Angle of the Operation Panel ... 3-20 Adjusting the Brightness of the Touch Panel ... 3-21 Adjust the Brightness of the Operation Panel Switch ... 3-21

Adjusting the Monitor ... 3-22 3-8-1 3-8-2 3-8-3

Adjust the Angle and Position of the Monitor ... 3-22 Adjust the Brightness of the Monitor ... 3-25 Setting combinations of Brightness ... 3-29

4 Troubleshootings 4-1

Messages ... 4-1

4-2

Message List ... 4-2

4-3

Assistance Messages ... 4-9

4-4

Other troubles ... 4-11 4-4-1

Image Display and Image Degradation ... 4-11

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 5-2-4

5-3

State of the Instrument and Accessories... 5-2 Clean the Instrument ... 5-4 Clean the Trackball ... 5-5 Clean the Air Filter... 5-6 Cleaning the Endo-cavity Probe Holder (Horizontal)... 5-7

Maintenance ... 5-9 5-3-1 5-3-2 5-3-3

Daily check: For Using the Instrument for a Long Period ... 5-10 Checking the Measurement Accuracy... 5-11 Safety Inspection... 5-18

6 Composition 6-1

Standard composition ... 6-1

6-2

Options ... 6-2 6-2-1 6-2-2

MN1-5368 rev.10

Recording instruments ... 6-2 Functional expansion instruments ... 6-3

7

6-2-3 6-2-4

Other accessories ... 6-3 Software ... 6-4

7 Probes 7-1

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

7-2

Probe specifications ... 7-6 7-2-1 7-2-2 7-2-3 7-2-4 7-2-5 7-2-6

7-3

Caution about Handling of Probes ... 7-1 Cautions about Cleaning and Storage ... 7-4 Convex Sector Probes ... 7-7 Linear Probes ... 7-11 Phased Array Sector Probes ... 7-15 Biplane Probes ... 7-18 3D Scanners... 7-19 Independent Probes ... 7-20

Clinical Measurement Range ... 7-21

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) ... 8-7 Thermal Index (TI)... 8-7

8-4

Setting condition influencing device output ... 8-9

8-5

Recommendation on ALARA principle ... 8-10

8-6

Default Setting ... 8-11

8-7

Acoustic output limits ... 8-11

8-8

Measurement uncertainties ... 8-12 8-8-1 8-8-2

8-9

Protocol for calculating the measurement uncertainties... 8-12 Results of measurement uncertainties ... 8-14

References ... 8-21

9 Acoustic Output Tables 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 9-3-4 9-3-5 9-3-6

8

List of symbols for Acoustic Output Tables ... 9-2 Convex Sector Probes ... 9-4 Linear Probes ... 9-100 Phased ArraySector Probes... 9-196 Biplane Probes ... 9-268 3D Probes ... 9-292

MN1-5368 rev.10

9-3-7

MN1-5368 rev.10

Independent Probes ... 9-310

9

10

MN1-5368 rev.10

1 Safety Precaution 1-1 Purpose of Use

1

Safety Precaution

1-1

Purpose of Use In the ultrasound diagnostic equipment, ultrasound images are produced as follows; Ultrasound wave palses released from transducer are reflected at the internal body system. Reflected wave are recieved by the transducer, and ultrasound image are produced with the reflected image on the monitor. You can distinguish internal body system because the acousitc impedances vary among the internal organs. Ultrasound images are used for various diagnoses, which reflected the internal body system. This equipment ProSound α7 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.

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.

MN1-5368 rev.10

1-1

1 Safety Precaution 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.

1-2

MN1-5368 rev.10

1 Safety Precaution 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 (including replacement of power cord) or remodel this instrument. Electic 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, take the probe away from the patient immediately, and stop using the instrument. If the patient’s condition is abnormal, provide appropriate medical treatment. When using this instrument, watch to make sure that it is functioning normally, and that the patient is not abnormally affected. • DO NOT connect any probes, options or accessaries or options to the prosound α7 which is not specified in this manual. There is a risk of injuries or burns of the patient or oprator. 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. There is a risk of unexpected accidents or electrical shock. For assemble or transport the equipment and its options, please contact one of our offices listed on back cover.

MN1-5368 rev.10

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1 Safety Precaution 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 with water or other liquids, avoid places salt-sulfur and avoid exposure to 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 not to slip, especially when using ultrasound gel or others. Return 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 connector, or USB connector sockets. • DO NOT touch the patient with parts other than the applied probe or the applied parts defined in the Chapter 2-2-3 in this manual. Doing so may cause electric shock or short circuitis. • Always use the instrument in dried state. 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 to stand for a while in the newly installed location in order for it to become acclimated to the environment before switching it ON. • DO NOT cover the vent. If the temperature gets hot, there is a risk of short-circuitting or other accidents. • Perform regular maintenance and inspection as indicated in this manual. When components of the equipment deteriorate due to years of use, there is a risk for degrading its performance, breaking down, emitting smoke or ignition. If you notice any problems, please contact one of our offices listed on back cover.

1-4

MN1-5368 rev.10

1 Safety Precaution 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. Faulure 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.

MN1-5368 rev.10

1-5

1 Safety Precaution 1-2 Precautions for Use

1-2-2

Labels Many marks are used in this equipment.

Labels that have a combination

and

(mainly connector sockets) includes following

safety caution;

DO NOT touch to the pins cropping out or nearing to them. There is risk of deterioration and failure of parts sensitive to static electricity. For details, See “Electrostatic Discharge (ESD) Guidelines” on page 1-20.

NOTE: Refer to probe documentation for more information on probe labels.

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. 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.

1-6

MN1-5368 rev.10

1 Safety Precaution 1-2 Precautions for Use

Labels on front side

(1)

(2) (4) (5) (3)

(1)

USB Connector Probe connection socket and socket number (1 to 3)

(2) Foot switch connection socket. (3)

IPX8: labels on the optional Foot switch (MP-2345B or MP-2614B) protented against the effects of continuous immersion in water.

(4) Be careful of catching your fingers. There is a risk of injury of your hands or fingers. (5) Follow instruction manual to move the instrument. The equipment could be hitted bump and turn over.

MN1-5368 rev.10

1-7

1 Safety Precaution 1-2 Precautions for Use

Labels on the Sides and Etc.

(1) (2)

connectors for the physiological signal

(1)

Type BF instrument DC-IN

connect the cable from the ECG output connector of the ECG monitor

(2) • In accordance with the instruction manual, adjust the height and angle of the operation Panel, and move the instrument. If you grip the probe holder, it may be a cause of its damage.

1-8

MN1-5368 rev.10

1 Safety Precaution 1-2 Precautions for Use

Labels on Back side

(1)

(2)

(3)

(4)

(1)

Method to fix the monitor arm Press the stopper, the monitor arm is fixed. Pick up the stopper, the monitor arm is unfixed.

(2) Warning sign and 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 waste the instrument as general waste. Comply with a local regulation.

2'8

(3)

(4)

MN1-5368 rev.10

Manufacturer

Model and manufacturer information

Potential Equalization trerminal

1-9

1 Safety Precaution 1-2 Precautions for Use Each marks on label (2) means following; Safety Warning sign.

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

Expolution

Do not use this instrument in a flammable atmosphere. It may cause an explosion if used in such an 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

Do not disassemble, repair (including replacement of power cord) or remodel this No instrument. Modification There is a risk of unexpected accidents or electrical shock.

DO NOT use portable radio communication devices (e.g. cellular phones and DO NOT radiotransceiver) near this instrument. use cellular Effects can include noise in images, disruption of physiological signals, and artifacts on phone thescreen.

DO NOT pushing

DO NOT sitting

1-10

Do not push the side of the equipment. Do not exert excessive force on the equipment. Doing so may cause the equipment to fall, which may cause injury or damage to other equipments.

DO NOT sit on the equipment. Doing so may cause the equipment to fall, which may cause injury or damage to other equipments. .

MN1-5368 rev.10