alpha_7_instruction_manual_safety_instruction_volum.pdf
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ULTRASOUND DIAGNOSTIC
INSTRUMENT
Instruction Manual
Safety Instruction
(volume 1/2)
Instruction manuals consist of this
manual, How to Use and
Measurement.
Before using this instrument, please
read Safety Instruction.
MN1-5368 rev.10
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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
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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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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
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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
Applicable part
of body
C
Applied part
A
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
A to C
A to C
N/A
Endocavity
–
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
MN1-5368 rev.10
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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
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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 ...............................................................................................................
Clean the Trackball .................................................................................................................
Clean the Air Filter...................................................................................................................
Cleaning the Endo-cavity Probe Holder (Horizontal)...............................................................
5-4
5-5
5-6
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
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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
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9-3-7
MN1-5368 rev.10
Independent Probes ............................................................................................................ 9-310
9
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10
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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.
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1-1
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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
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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.
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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
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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.
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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
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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.
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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
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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
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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. .
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1 Safety Precaution
1-2 Precautions for Use
Follow the instruction manual to operate this instrument.
Follow the
instruction If not avoided, may result in injury, property damage, or the equipments trouble.
manual
1-2-3
Precautions concerning acoustic power
The tissues of the human body consist of soft tissues, water, bone, and other tissues. Ultrasound
energy is progressively absorbed and attenuated by the body as it penetrates it, hence tissues
located behind water, which causes only a small degree of attenuation, receive a relatively large
amount of ultrasound energy. Also, it is necessary to be careful of bioeffects due to heat in the
vicinity of tissues, such as bone, that readily convert ultrasound energy into heat.
Particularly, a fetus at the bone formation stage is exposed to a high risk of damage due to
heating because almost all of the ultrasound energy passes through the amniotic fluid without
being attenuated. Even in the case of a fetus prior to bone development, the cells are active,
hence there is a possibility of growth being affected, even when the temperature rise is low.
Mechanical bioeffects such as vibration and cavitation occur when the body is exposed to
ultrasound energy for a long period. You can reduce the risk of damage to the tissues by
interrupting the ultrasound energy before it reaches the level at which tissue damage occurs.
To this end, it is necessary to obtain a grasp of the functions of the instrument, acquire
familiarity with the method of operating it, and understand the parameters that affect the
acoustic power. Also, get into the habit of always freezing the image as soon as you have
obtained the necessary diagnostic information.
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.
Select the optimum setting for the region to be examined while observing the acoustic power
index.
There is the possibility that the patient’s internal tissues could be affected.
Ultrasound energy is converted into heat in the body while being attenuated. Particularly,
there is a possibility of heat being generated in bone and the cranium compared to soft tissue.
DO NOT select doppler modes for routine fetal examinations.
Doppler modes in fetal examinations are only to be used where clinically indicated, such as in
known or suspected high risk pregnancies.
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1 Safety Precaution
1-2 Precautions for Use
1-2-4
Precautions for Use in Conjunction with Drugs
• Precautions for use in Conjunction with an ultrasound contrast agent
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 agents
have 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 general 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.
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Precautions for Use in Conjunction with Other Medical Devices
• Equalize the potential between this instrument and other instrument
This equipment has a potential equalization terminal. The potential equalization terminal
is on the back panel. For equalizing the potential, connect between the potential
equalization terminals.
• Use in conjunction with devices which use high frequencies
High frequency surgical instruments may be used to deliberately apply an
electromagnetic field or electric current of high frequency to the patient.
This instrument has not been equipped with any means to protect the patient from burn
injury from any of its parts when it is used together with a high-frequency surgical
instrument.
• Use in conjunction with a cardiac defivrillator
Do not use a cardiac defibrillator while a physiological signal is on display.
Keep probes and physiological electrodes away from a patient body surface when a
cardiac defibrillator is used.
• 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.
• 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 apply excessive force for insersion.
Damage an insulating membrane and the patient or the examiner could be burned. Use an
attachment with the electrode to allow suitable guidance of the puncture.
• Do not use in conjunction with a cardiac defivrillator.
It may cause the instrument break down.
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Guideline for Electromagnetic Compatibility
The electromagnetic compatibility (EMC) is ability of device to function satisfactorily in its
electromagnetic environment without introducing intolerable electromagnetic disturbance to
anything in that environment.
Medical devices, communications devices, radio and TV broadcasting antennae and similar
devices can both emit electromagnetic waves and receive interference from them. As an
ultrasound diagnostic instrument receives radio frequency signals (ultrasonic wave signals on
radio frequencies), it can receive electromagnetic disturbance emitted by electromagnetic
energy sources. Effects can include noise in images, disruption of physiological signals, and
artifacts on the screen.
For prevent electromagnetic disturbances, there are three notes: (1) use conjunction with other
medical devices, (2) electromagnetic environment, (3) use of portable and mobile RF
communications equipment.
IMPORTANT: The doctor must consider whether electromagnetic disturbance could cause any
artifacts which affect images or diagnoses.
1)
Use in Conjunction with Other Medical Devices
When this system receive electromagnetic disturbances, effects can include noise in
images, disruption of physiological signals, and artifacts on the screen. The Position this
instrument and its cables (e.g. probe cables, ECG cables, I/O cables, etc.) as far away as
possible from other medical electrical instrument.
2)
•
Check that the instrument do not to affect by electromagnetic disturbance emitted from any
other device and that electromagnetic disturbances emitted by this instrument have adverse
effects on any other devices.
•
Use in conjunction with High frequency surgical equipment, this instrument may be
affected with interference when it is drawing monochrome or color images
•
If electromagnetic radiation from this instrument causes abnormal operation to other
medical electrical instruments nearby, stop using immediately. Do not use this device in
conjunction with such effected instruments.
Electromagnetic environment
For the purposes of preventing electromagnetic interference, this instrument is intended
for use in hospitals, research institutions and similar facilities.
3)
•
Position this instrument as far away as possible from the radio receiver, TV set, and its
cables and antenna. The electromagnetic radiation from this instrument may cause the
disturbance to the radio receiver,TV set, etc.
•
If the instrument is to be used near a motor (elevator, pump room, etc.), power transmission
line or wireless instrument, it is necessary to electrostatically shield it.
Use of portable and mobile RF communications equipment
Do not use portable radio communication devices (e.g. cellular phones and radio
transceiver) near this instrument. Use of portable and mobile RF communications
equipment such as cellular phones, transceivers, and amateur radio instrument can affect
the operation of this device.
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Electromagnetic compatibility
The electromagnetic compatibility (EMC) of this device is in conformity with theIEC
60601-1-2: Ed.3, which is the international standard for EMC of medical instruments. This
standard prescribes the testing of the level of electromagnetic energy emanates from a
equipment (electromagnetic emission) and the tolerance of a equipment for elecromagneic
disturbance(electromagnetic immunity).
Testing of our ultrasound diagnostic devices has confirmed that they emit no electromagnetic
energy which contravene standards.
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Guidance and manufacturer’s declaration –electromagnetic emissions
The ProSound α7 is intended for use in the electromagnetic environment specified below.The
customer or the user of the prosound α7 should assure that it is used in such an environment.
Emissions test
RF emissions
Compliance
Group 1
The ProSound α7 uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
Class B
The ProSound α7 is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public lowvoltage power supply
network that supplies buildings used for
domestic purposes.
CISPR11
RF emissions
CISPR11
Harmonic emissions
Electromagnetic environment －
guidance
Class A
IEC61000-3-2
Voltage fluctuations/flicker emissions Complies
IEC61000-3-3
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