prosound -α 6 Instruction Manual Accompanying CD-ROM Document rev 04

Viewing the instruction manual on the CD-ROM NOTE: Adobe Reader version 7 or higher is necessary to display the manuals on the

CD-ROM. If Adobe Reader is not installed on your computer, please download Adobe Reader from the Home page of Adobe Systems Incorporated.

1.

Insert the supplied CD-ROM into the CD-ROM drive.

2.

Open the DVD/CD drive. The instruction manuals consists four books. •

Safety Instruction: provides instructions for the safe use of the instrument, acoustic power tables (only USA), and how to avoid hazards.

•

How to Use: describes functions for adjusting, displaying and recording images.

•

Measurement: describes measurement methods on an ultrasound image and viewing reports.

•

Power Data Book (except USA): provides acoustic output tables of probes.

Example of instruction manuals on the CD-ROM. (Figure is different from composition of the instruction manuals.) Gray area in the above figure shows (parts of ) the name of the instrument.

3.

Double-click an instruction manual →

A selected instruction manual is displayed. Paper size of the instruction manuals on the CD-ROM is Letter size. Before printing, check your printer property.

CONTENTS Precautions for Use of the Device

→ p.3

Name of Each Parts

→ p.6

Moving and Installing the Instrument

→ p.8

Probes

→ p.10

Connecting with Others

→ p.11

The Flow of the preparation to the study

→ p.11

After Using the Instrument and Cleaning

→ p.13

Troubleshootings

→ p.14

Classification

→ p.15

Specification

→ p.16

In this manual, the following items are important in preventing harm or injury to equipment operator or patient. 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.

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MN1-5763 rev.4

Precautions for Use of the Device The ProSound α6 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.

PRECAUTIONS Concerning the Use or Management of the Device • Only physicians and other qualified personnel should operate this equipment for diagnostic purposes. • Scan for the minimum length of time necessary for the diagnosis, and at the lowest suitable output. For acoustic output, refer to Chapter 8 of the Safety Instruction manual. • Do not disassemble, repair or remodel this equipment or optional features without our consent. Repairing of this equipment shall be performed by a third party certified by the manufacturer. Please contact one of our offices listed on back cover. 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.

• 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 Instruction manual 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 Concerning the Install of the Device 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. For details, refer to the Chapter 3 of the Safety Instruction Manual. • 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.

• Connect probes, options or accessaries or options to the device which is specified in the Safety Instruction manual. • Transporting this equipment (by vehicle/ship) shall be performed by a third party certified by the manufacturer. Please contact one of our offices listed on back cover. • Place instrument under the condition suitable for:

Conditions Ambient

Working environment 10 ℃ to 40 ℃

Storage environment Moving or Transporting environment -10 ℃ to 50 ℃

temperature Relative humidity 30％ to 75％ (non condensing) 10％ to 90％ (non condensing)

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Conditions Atmospheric

Working environment

Storage environment Moving or Transporting environment

700 hPa to 1060 hPa

700 hPa to 1060 hPa

< 3,000m

-

pressure Altitude

• 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, and avoid exposure to direct sunlight. • Do not sit on or push the instrument. • If the temperature is different from the new and the previous installation location, leave the instrument to stand for a while in the new installed location to allow it to become acclimated to the environment. • Adjusting the height of the operation panel or position of the monitor, be careful of catching your fingers. • Install in an environment that ensures electromagnetic compatibility, in accordance with section 1-2-6 of the Safety Instruction manual, "Guideline for Electromagnetic Compatibility", and Item 1-3, "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.

• When the instrument is installed or moved, perform the inspection before using in accordance with Section 3-5 of the Safety Instruction manual.

Precautions for Use in Conjunction with Drugs • If you perform an ultrasound examination after having the patient ingest a general drug, the ultrasound may affect the pharmacological effect of the drug. Before using a general drug, carefully read the instructions provided, and any cautionary notes. • If you wish to use an ultrasound contrast agent, be sure to use only a substance that has been approved for use for that purpose. See the specific package insert for the contrast agent being used for details. Watch to make sure that the patient is not abnormally affected during the exams using the ultrasound contrast agent. Cardiac rhythm disturbances during perfusion studies using gas ultrasound contrast agentshave been observed in the diagnostic range of Mechanical Index (MI) values. See the specific package insert for the contrast agent being used for details.

Precautions for Use in Conjunction with Other Medical Devices • Use only medical equipments that conforms to IEC60601-1 together with this instrument. For handling and safety inspection on the medical equipment to be used with this instrument, refer to the instruction manual of the medical equipment. • Use the equipotential terminal as the equipotential conductors when interconnecting or grounding with other equipment. 4

MN1-5763 rev.4

Keep probes, body parts and puncture instruments away from the course of high-frequency currents. Failure to observe the following precautions could result in burns to the patient or the examiner. With these radiated high frequencies, the device may be affected with interference when it is drawing monochrome or color images. Operate the device with caution paying attention to the positions of the counter electrode plates and the connecting cord against the probe. Do not use in conjunction with a cardiac defibrillator. It may cause the instrument break down. When using this instrument together with other electronic medical appliances, position it and its cables (e.g. probe cables, ECG cables, I/O cables, etc.) as far away as possible from other appliances and their cables. Note that electromagnetic radiation from this instrument may cause other electronic medical instruments nearby to function abnormally. If such interference occurs, stop using the other instrument together with this one.

Precaution in the Handling of Probes • Connect probes to the instrument which are specified in the Safety Instruction manual. • For specification and handling a probe, refer to the instruction manual for a probe.

Precaution for the Inspection and Cleaning • Before using the instrument, perform the inspection in accordance with Section 3-5 of the Safety Instruction manual. After using the instrument, clean the instrument, probes, and peripherals. • Perform regular inspections to ensure the safe use of the instrument and maintain performance. For details, refer to the Chapter 5 of the Safety Instruction manual.

Precautions for the 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, 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. And please contact one of our offices listed on back cover. 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.

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5

Cutting Off the Power Disconnect the power plug out from the power outlet.

Name of Each Parts

1) 9)

(1)

Viewing Monitor (15-inch in the figure)

(2)

Touch panel

(3)

Operation panel

(4)

Handle

(5)

USB connector (Used for connecting to the

2) 10)

USB flash memory (stick type only)) (6) (7)

3)

Independent probe connector (option) Foot switch connector (Foot switch is optional.)

11)

(8)

Pedal for adjusting the height of the operation panel

4)

(9)

5)

(10) Cable hook

Cable hanger

(11) Probe holder 6)

(12) Casters

7) 8)

12)

Front view and Back view

1)

3)

(1)

Keyboard (option)

(2)

Electronic probe connectors

(3)

Equi-potential terminal

(4)

Handle

(5)

Physiological signal connector (option)

(6)

Circuit Breaker

(7)

Power socket (for connecting the power cable)

4) 2)

5) 6) 7)

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MN1-5763 rev.4

Operation Panel

6)

7)

1) 8) 2) 9)

3) 4)

10)

5) 11)

(1)

POWER switch

(2)

ID switch

(3)

+ switch

(4)

MEASUREMENT switch

(5)

PRINT 2 switch

(6)

Rotary Encoder (used for the menu displayed the left section of touch panel)

(7)

STC knob

(8)

Rotary Encoder (used the trackball to provide supplementary control)

(9)

PRINT 1switch

(10) (Pushing) FREEZE switch (Rotating) B GAIN switch (11) Trackball

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Moving and Installing the Instrument 1.

Press POWER to turn off.

2.

Prepare for moving. Power cable

1 After shutdown is completed, Unplug the cable from outlet. 2 Lightly coil the power cable and hang it on the cable hanger.

Probes

Store in the probe holder. Bunch the cables so that they do not protrude from the instrument or get caught beneath the casters. Or disconnect the probe, and then place it in its case.

Operational panel

Face the front.

Keyboard(option)

Push the keyboard into place beneath the operation panel.

3.

Release the lock lever of the caster.

4.

Grasp the handle firmly when moving the instrument. CAUTION: Move the instrument keeping distance that it does

not come in contact with people, peripheral equipment, walls, posts, doors and the like. Move carefully the instrument at a long distance, tilt it, or move it along a passageway that has stairs.

Moving across an area with uneven floor levels (1) 1 Face the instrument in the opposite direction of movement. 2 Use the handle to lift the instrument over the uneven surface. 3 After clearing the bump, return the instrument to a forward-facing position Moving across an area with uneven floor levels (2) Use the handle of the back side to lift the instrument over the uneven surface.

NOTE: DO NOT grip the cable hanger, operation panel, monitor, or probe holder to lift or move

the equipment.

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MN1-5763 rev.4

5.

When positioning it at an installed location, fix casters.

6.

Inspect the state of the instrument. •

Ensure that there are no loose parts, damage, or signs of wear on the instrument.

•

If the temperature is different from the new and the previous installation location, leave the instrument to stand for a while in the new installed location to allow it to become acclimated to the environment.

7.

Adjust the position of the operation panel or monitor. Adjust the Operation panel 1 Remove the cable from the cable hanger. 2 While your foot is still on the pedal located under the main unit, in the middle, grip the handle on the operation panel to adjust the height of the operation panel. 3 Release the pedal. The height of the operation panel is fixed.

Adjust the Angle and Position of the Monitor 15 inch monitor

17 inch monitor

Grasp the monitor

Grasp the handle of the

frame with both

monitor and adjust the monitor.

hands and adjust the monitor.

MN1-5763 rev.4

handle

8.

Insert the power plug of the power cable attached to the instrument into the power outlet (hospital grade).

9.

Press POWER to turn ON.

10.

Check the operation. •

Images and characters are displayed on the screen.

•

Ensure that current time and date are displayed.

•

Ensure that the connected probe, the image display and the frequency match each other. When no probes are connected, ensure that ”NO PROBE “ is displayed.

9

Probes Connect probes to the instrument which are specified in the Safety Instruction manual. For specification and handling a probe, refer to the instruction manual for the probe. • Use probes only for their intended purpose which are specified in the Safety Instruction manual or the instruction manual for the probe. • Clean, disinfect and sterilze the probes as described in their documentation, before using them. • Perform the external inspection of and probe, ensure that there are no holes, depressions, cracks, deformation on the connecting parts of probe. If you find the probes tobe defective, stop using it immediately. • For puncture operation, refer to the Safety Instruction manual, How to Use manual, or the instruction manual of a probe.

Connecting a probe to the instrument 1.

Press FREEZE to freeze the image.

2.

Turn the lock lever counterclockwise to the RELEASE position.

3.

Insert the connector of the electronic type probe into the electronic probe connector on the instrument. RELEASE

LOCK

lock lever

4.

Turn the lock lever clockwise to the LOCK position. RELEASE

LOCK

lock lever

If the lock lever is difficult to turn, reinsert the connector.

5.

Adjust the cable of the probe so that it does not get tangled with the strap of the USB flash memory and does not grind against the floor.

Removing a probe from the instrument

10

1.

Press FREEZE to freeze the image.

2.

Turn the lock lever counterclockwise to the RELEASE position.

3.

Remove the probe from the instrument.

MN1-5763 rev.4

Connecting with Others For connecting the foot switch or physiological signal cables, refer to the Chapter 3 of the Safety Instruction manual.

The Flow of the preparation to the study 1.

Perform the external inspection of the instrument and probes. Ensure that there are no scratches, cracks, depressions, change of color.

2.

Insert the power plug into the power outlet (hospital grade).

3.

Connect a probe to the probe connector on the instrument.

4.

Press POWER to turn on, and then check the screen display.

5.

Press NEW PATIENT, and then input a patient information.

6.

Coat the ultrasonic irraditaion area of the probe and area to be examined of a patient with an ultrasound medium.

7.

Apply the probe to the examined area of a patient, and then display an image.

8.

When the images are acquired necessary for the diagnosis, and then press FREEZE.

Operating Mode B mode

1 Press B or B/B. 2 Adjust an image. • Using DEPTH/RANGE, adjust size of a tomographic view.

M mode

• Using B Gain knob or STC knob, adjust the sensitivity. 1 Press M. 2 Using trackball, move the M cursor on the B mode image. 3 Using B Gain knob, control balance of the sensitivity between B mode and

PW mode

M mode. 1 Press PW. 2 Using trackball, Move the Dop cursor on the B mode image. 3 Adjust an image. • Using VEL RANGE, adjust the range of the flow velocity.

CW mode

• Using D Gain knob (PWswitch), adjust the sensitivity 1 Press CW. 2 Using trackball, Move the Dop cursor on the B mode image. 3 Adjust an image. • Using VEL RANGE, adjust the range of the flow velocity.

Flow mode

• Using D Gain knob (PWswitch), adjust the sensitivity 1 Press B, B/B, or B/M, and then press FLOW.

(Color Doppler)

2 Adjust an image. • Using VEL RANGE, adjust the range of the flow velocity. • Using Flow Gain knob, adjust the sensitivity

MN1-5763 rev.4

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Freezing image/Unfreezing image • Press FREEZE.

Measuring on a ultrasound image 1.

Press Measurement.

2.

Select the measurement item on the touch panel.

3.

Measure according the selected item. (Refer to the Measurement manual).

Printing images or Storing images • To Store a still image a

Press FREEZE to stop an image.

b

To print, press PRINT. To store (save), press STORE.

• To store a moving image a

Press FREEZE to unfreeze an image.

b

Press STORE to start storing an moving images.

c

To stop storing, press STORE.

A moving image is acquired for time or heart beats depending the preset setting.

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MN1-5763 rev.4

After Using the Instrument and Cleaning DO NOT sterilize or disinfect the equipment with medicinal solution or gas.

1.

Wipe off ultrasound medium remaining on the patient body surface.

2.

Put POWER for one second or more to turn off the power.

3.

Disconnect the power plug from the wall outlet after shutdown is complete. Roll the power cable softly and hang it in the cable hanger.

4.

Wipe off ultrasound medium remaining on the probes.

5.

Store probes in the probe holder or remove probes from probe connectors.

6.

Clean the instrument and installation location. NOTE: DO NOT clean the instrument with organic solvents such as alcohol or commercial

LCD cleaners. Operation panel, enclosure, probe holder, and foot switch Clean them with a soft, dry cloth. If they are very dirty, remove the dirt in the following procedure. a)

Immerse a soft cloth in a weak solution of a neutral detergent, and wring water out of it.

b) c)

Wipe the instruments with it softly and clean the dirt. Wipe off the detergent.

NOTE: For cleaning the trackball, refer to the Chapter 5 of Safety Instruction manual.

Monitor Immerse a soft cloth in water and wring out, wipe the monitor with it softly. Air filters There are the air filters at the following position.

a

Remove each magic fastener of the air filter from bottom of the instrument. And then remove each air filters from the slit.

b

Vacuum-clean the filter. If dirt is heavy, clean it off carefully with a soft cloth moistened with neutral detergent.

c

Dry the filter completely in a shaded area

d

Insert the filters all the way in the slit.

e

Put each magic fastener under the bottom of the instrument.

Installation location and Power plug Clean and remove moisture. If you use the instrument in a dusty location, the ventilation may deteriorate which can cause malfunction of the instrument. Probes Cleaning, disinfection, and sterilization methods vary according to the probe.

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Troubleshootings When the situation is not improved even if you treat the following, please contact one of our offices listed on back cover.

For message on the screen, refer to the chapter 4 of the Safety Instruction manual.

The equipment is freezed Cause

Action

Runaway software

1 Unplug the power cord from the outlet.

Power supply is

2 Let stand few minuites and insert the power plug of the power cable attached to the instrument into the power outlet.

fluctuated.

3 Press Power to turn on

The date and time on screen are not correct Cause

Action

Date and time is not Adjust the date and time on Common Preset set or is shifted. Internal battery is

Please contact one of our offices listed on back cover.

drained.

Image Display and Image Degradation Confirm the state of the Power switch and monitor, and then deal according to the following. POWER switch

Monitor Display Graphic

Image

Light out −

−

Lit on orange

−

−

Cause

Action

No connection of

Reconnect the power plug into the power

the power cable.

outlet.

Circuit breaker is

Check the condition of the circuit breaker of

tripped.

the connected power outlet.

The instrument

Press Power.

status is standby.

If start is finished on the way, please contact one of our offices listed on back cover.

Lit on Blue

No

No

The OSD setting is

Adjust the setting of the monitor with the

different.

OSD menu.

EXT (external input) Turn off EXT from the touch panel menu. is turned on.

Lit on Blue

Yes

No

Gain is lowered.

Adjust the setting with the B Gain knob.

No connection of

Reconnect the probe.

the probe. Acoustic power is lowered.

Adjust the setting with the Acoustic Power knob.

The still image is

Press the FREEZE switch to switch the

displayed (The

display to real time.

freeze switch is ON). 14

MN1-5763 rev.4

Classification • Protection against electric shock (ME equipment): class I • ME equipment • Protection Against Electric Shock (Applied Parts): Type BF Applied Part ‒

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

C

A

connector

D

connector

C

A

The probe/scanner pattern diagram. Above illustrates a surface/intraoperative probe. Below shows a coelomic probe.

Applicable part of body

Applied part

parts treated as applied parts

B - C length

surface of body

Ultrasonic irraditaion area (D)

A to B

100 cm

Intraoperative

Ultrasonic irraditaion area (D)

A to B

20 cm

Endocavity

A to C

A to C

-

‒

ECG The 2-meter length of the ECG cable extending from the ECG electrodes is treated as applied part (see diagram below). 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)

• According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide: Instrument is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. • Suitability for use in an oxygen rich environment: Not suitable • Mode of operation: Continuous operation

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Specification Scanning mode

Electronic convex scanning, Electronic linear scanning, Electronic sector scanning

Display mode

B, M, PW doppler, CW doppler, Color doppler

Measurement

Basic measurement, Cardiac Measurement, Vascular Measurement,

Functions

Abdominal measurement, Obstetrical Measurement, Gynecological Measurement, Urological Measurement, eTRACKING Measurement, Small Parts Measurement

Rated supply

100V to 120V, 200V to 240V

voltages Rated frequency

50 / 60 Hz

Power input

900VA

Viewing monitor

15-inch or 17-inch flat-panel LCD

Dimensions

420 mm (width), 700 mm (Depth), 1303 mm to 1533 mm (height when the monitor is 15-inch type) 1368 mm to 1618 mm (height when the monitor is 17-inch type)

Weight

Approx.104 kg For details, please refer to the Safety Instruction Manual.

About Handling CD • Do not store this disk in hot or humid place. Avoid exposure to direct sunlight or illumination. • Do not stick paper or tape to disk. • Do not write disk in a pen. • Prevent you from touching the both sides when you have a disk. • Handle it so that a fingerprint, a dirt, dust, a drop of water do not stick to a disk. Handle it not to damage a disk. • After use, correct a disk to a case. • Do not throw this disk. human body and others may be injured.

6-22-1 Mure, Mitaka-Shi, Tokyo, 181-8622 Japan TEL +81-422-45-6049 URL: http://www.hitachi-aloka.com Overseas Offices: Hitachi Medical Ultrasound Logistics, Zweigniederlassung der Hitachi Medical Systems Europe Holding AG Carl-Zeiss-Strasse 5, D-72555 Metzingen, Germany ProSound logo is a registered trademark or trademark of Hitachi Aloka Medical, Ltd. in the Japan and/or other countries. Microsoft, and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. Adobe, Acrobat, and Reader are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and /or other countries. All brand name, product name, and system name are registered trademarks or trademarks of their respective owners. In this manual, ™ and ® are omitted. Copyright©Hitachi Aloka Medical,Ltd. All rights reserved. 2014.03

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