f75_instruction_manual_measurement_safety_instructi.pdf
Page 1
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.
MN1-5670 rev.1
Page 2
The prosound logo are registered mark of ALOKA co., ltd. in Japan and other countries.
Copyright©2010 ALOKA co.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 Videosoft Corporation. Portions of this software are based in part on the work of the
Independent JPEG Group. VS-FlexGrid Pro copyright©2000 Videosoft Corporation.
Real-time Tissue Elastography is a registered trademark of Hitachi Medical Corporation. The Real-time Tissue
Elastography include technology used under license of Hitachi Medical Corporation.
MN1-5670 rev.1
Page 3
INTRODUCTION
Introduction
This is an instruction manual for model prosound F75, 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 the operator of the equipment
and the patient. There are 4 levels of harm/damage that can be caused by ignoring instructions/displays and using the equipment incorrectly: "Danger," "Warning," "Caution," and
"Note."
These types are indicated by the following symbols.
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 equipments and also to ensure effictive
use.
Contents of cautions shows the following graphics.
This mark means the corresponding item is "alerted".
This mark means the corresponding item is "prohibited".
This mark means the corresponding item is required.
The format of this document shows the following comtents.
NOTE:
shows common notes.
IMPORTANT:
shows important considerations.
Input items, output from the equipment and messages on screen are described as message.
Menu ane Switches are described as Menu. Sub-menus under the main menu are described as
Menu > sub-menu > sub-menu.
MN1-5670 rev.1
3
Page 4
INTRODUCTION
About the model “prosound F75”
The prosound F75 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 F75
•
Do not disassemble, repair or remodel this equipment or optional features without the
consent of ALOKA.
NOTE:
Disassemble is removing the parts or options from the equipment using tool.
NOTE:
Remodel is installing or connecting the unspecified parts or equipments,
including replacement of power cord.
•
Assemble of the equipment or optional accessories shall be performed by a third party
certified by ALOKA. Please contact any of our offices listed on the back cover.
NOTE:
Assemble is installing and connecting the parts or optional accessories in
the main equipment using tool.
2)
•
Transporting this equipment (via automobile/ship) shall be performed by a third party
certified by the manufacturer. Please contact any of our offices listed on the back cover.
•
Please conduct routine cleaning and inspection of the equipment. Refer to Chapter 5 of the
Safety Instruction for details. .
•
Ensure that the output level of the scan conforms to the required duration of diagnosis.
•
If any malfunction or abnormality is discovered during operation of the equipment, remove
the probe from the patient immediately and discontinue use. If any abnormality is observed
in the patient, provide proper care as quickly as possible. Refer to Chapter 4 of the Safety
Instructions for more information on dealing with the equipment appropriately. If the
malfunction is not listed in Chapter 4 of the Safety Instructions, contact our offices listed
on the back cover.
PRECAUTIONS for the prosound F75 Installation
This equipment is a medical electrical equipment that intended for use in hospitals,
research facilities. The equipment 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 Instructions.
•
Install in an environment that ensures electromagnetic compatibility, in accordance with
section 1-2-6 of the Safety Instructions, "Precautions Concerning the Maintenance of
Electromagnetic Compatibility," and Item 1-3, "Guidelines for Electromagnetic
compatibility."
NOTE:
The electromagnetic compatibility (EMC) is ability of device to function
satisfactorily in its electromagnetic environment without introducing intolerable
electromagnetic disturbance to anything in that environment.
4
MN1-5670 rev.1
Page 5
INTRODUCTION
Classification of model “prosound F75”
• Protection against electric shock (ME equipement): 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
A
C
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
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
MN1-5670 rev.1
5
Page 6
CONTENTS
1 Safety Precautions
1-1
Purpose of Use ...................................................................................................................... 1-1
1-2
Precautions for Use ............................................................................................................... 1-2
1-2-1
1-2-2
1-2-3
1-2-4
1-2-5
1-2-6
1-3
Electromagnetic compatibility .............................................................................................. 1-16
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 ................................................................................ 1-12
Precautions for Use in Conjunction with Drugs ..................................................................... 1-13
Precautions for Use in Conjunction with Other Medical Devices........................................... 1-14
Guideline for Electromagnetic Compatibility.......................................................................... 1-15
Guidance and manufacturer’s declaration –electromagnetic emissions ............................... 1-16
Essential performance........................................................................................................... 1-17
Guidance and manufacturer’s declaration – electromagnetic immunity ................................ 1-18
Guidance and manufacturer’s declaration – electromagnetic immunity ................................ 1-19
Recommended separation distances between portable and mobile RF communications
equipment and the prosound F75 ........................................................................................1-20
Electrostatic Discharge (ESD) Guidelines ........................................................................... 1-21
2 Specifications 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 model “prosound α6” ..................................................................................... 2-7
Name of Each Parts ............................................................................................................... 2-8
2-3-1
2-3-2
Exterior .................................................................................................................................... 2-8
Operation Panel .................................................................................................................... 2-12
3 Preparation 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 ............................................................................................................ 3-9
3-3-1
3-3-2
3-4
6
Connecting a Probe to the Instrument..................................................................................... 3-4
Connect the Physiological Signal Connector .......................................................................... 3-5
Connecting with Other Instrument ........................................................................................... 3-7
Isolate from the supply main ................................................................................................... 3-9
Moving equipment ................................................................................................................. 3-10
Storing the Instrument .......................................................................................................... 3-13
MN1-5670 rev.1
Page 7
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
3-7
Character Display .................................................................................................................. 3-16
Graphic Display ..................................................................................................................... 3-18
Adjusting the Operation Panel ............................................................................................. 3-20
3-7-1
3-7-2
3-7-3
3-7-4
3-8
External Inspection ................................................................................................................ 3-14
Operation Check ................................................................................................................... 3-15
Adjusting the Operation Panel...............................................................................................
Adjust the Horizontal and Vertical Position and Orientation of the Operation Panel .............
Changing the Labeling of the Operation Panel Switches ......................................................
Adjusting the Brightness of the Operation Panel Switch .......................................................
3-20
3-21
3-22
3-23
Adjusting the Monitor ........................................................................................................... 3-24
3-8-1
3-8-2
Adjusting the Monitor position ............................................................................................... 3-24
Adjusting the Brightness of the Monitor and the Touch Panel .............................................. 3-26
4 Troubleshooting
4-1
Messages ............................................................................................................................... 4-1
4-2
Dialog messages ................................................................................................................... 4-2
4-3
Assistance messages ............................................................................................................ 4-5
4-4
Other troubles ........................................................................................................................ 4-7
4-4-1
Image Display and Image Degradation ................................................................................... 4-7
5 Maintenances
5-1
After Using the Instrument ..................................................................................................... 5-1
5-1-1
5-2
Cleaning ................................................................................................................................. 5-3
5-2-1
5-2-2
5-2-3
5-3
State of the Instrument and Accessories................................................................................. 5-2
Clean the Instrument ............................................................................................................... 5-4
Cleaning the Trackball............................................................................................................. 5-5
Cleaning the Air Filter .............................................................................................................. 5-6
Maintenance .......................................................................................................................... 5-7
5-3-1
5-3-2
5-3-3
Daily check: For Using the Instrument for a Long Period ........................................................ 5-8
Checking the Measurement Accuracy..................................................................................... 5-9
Safety Inspection................................................................................................................... 5-16
6 ACCESSORIES and OPTIONS
6-1
Product composition .............................................................................................................. 6-1
6-2
Options ................................................................................................................................... 6-2
6-2-1
6-2-2
6-2-3
6-2-4
MN1-5670 rev.1
Recording Devices ..................................................................................................................
Functional Expansion Units .....................................................................................................
Other devices ..........................................................................................................................
Softwares ................................................................................................................................
6-2
6-3
6-3
6-3
7
Page 8
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
7-3
Caution about Handling of Probes .......................................................................................... 7-2
Cautions about Cleaning and Storage .................................................................................... 7-4
Convex Sector Probes ............................................................................................................ 7-7
Linear Probes .......................................................................................................................... 7-9
Phased Array Sector Probes ................................................................................................. 7-10
3D Scanners and Independent Probes ................................................................................. 7-11
Clinical Measurement Range ............................................................................................... 7-12
8 Acoustic Output Safety Information
8-1
Acoustic output index ............................................................................................................. 8-1
8-2
Interaction between ultrasound and tissues ........................................................................... 8-3
8-2-1
8-3
Possible Biological Effects ...................................................................................................... 8-4
Derivation and Meaning of MI / TI .......................................................................................... 8-6
8-3-1
8-3-2
Mechanical Index (MI) ............................................................................................................. 8-6
Thermal Index (TI) ................................................................................................................... 8-7
8-4
Setting condition influencing device output ............................................................................ 8-9
8-5
Recommendation on ALARA principle ................................................................................. 8-10
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 .......................................................................................................... 9-3
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 ............................................................................. 9-3
Convex Sector Probes ............................................................................................................ 9-5
Linear Probes ........................................................................................................................ 9-47
Phased ArraySector Probes .................................................................................................. 9-66
3D Probes ............................................................................................................................. 9-97
Independent Probes ............................................................................................................ 9-103
MN1-5670 rev.1
Page 9
1 Safety Precautions
1-1 Purpose of Use
1
Safety Precautions
1-1
Purpose of Use
In the ultrasound diagnostic equipment, ultrasound images are produced as follows;
Ultrasound wave pulses released from transducer are reflected at the internal body system.
Reflected wave are transmitted the transducer, and ultrasound image are produced with the
reflected image on the monitor. You can distinguish internal body system because the acoustic
impedances vary among the internal organs.
Ultrasound images are used for various diagnoses of the internal body system.
This equipment prosound F75 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.
MN1-5670 rev.1
1-1
Page 10
1 Safety Precautions
1-2 Precautions for Use
1-2
Precautions for Use
Before using this equipment, please read this manual. Especially be sure to read "1. Safety
Precautions".
Keep this manual securely for future reference.
The following items are important in preventing harm or injury to the operator of the instrument
and the patient. There are 4 levels of harm that can be caused by ignoring instructions or displays
and using the instrument incorrectly: "Danger," "Warning," "Caution," and "Note.
Indicates an imminently hazardous situation which, if not avoided, will
result in the death or serious injury of the operator of the equipment.
Indicates a hazardous situation which, if not avoided, may result in death or
serious injury.
Indicates a hazardous situation which, if not avoided, may result in slight or
moderate injury, or property damage.
Indicates a request concerning an item that must be observed in order to
prevent damage or deterioration to instruments and also to ensure effective
use.
These types are indicated by the following symbols.
This symbol means the corresponding item is "alerted."
This symbol means the corresponding item is "prohibited."
This symbol means the corresponding item is required.
1-2
MN1-5670 rev.1
Page 11
1 Safety Precautions
1-2 Precautions for Use
1-2-1
Warnings and Safety Notice
• Do not use this instrument in a flammable atmosphere.
This equipment is not suitable for use in a flammable environment. It could cause an
explosion.
• Do not disassemble, repair or remodel the equipment or optional features without the
consent of ALOKA.
Electic shock or other accidents could result.
Please contact any of our offices listed on the 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 or options to the prosound α6 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.
For assemble or transport the equipment and its options, please contact one of our office listed
on back cover.
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, and avoid exposure to direct sunlight.
These locations may cause injuries such as burns to the patient or examiner.
MN1-5670 rev.1
1-3
Page 12
1 Safety Precautions
1-2 Precautions for Use
• 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. Hold the
unused probe in the probe holder.
Otherwise, the probe may slip out of your hands and hit a patient or a examiner.
• Coating the probe with an ultrasound medium before using.
• When 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 to the exposed sockets of probe connectorsm physiological signal cable
connectors, or USB connector sockets.
• DO NOT touch to the patient with parts of other than applied parts and parts treated as such..
Doing so may cause electric shock or short circuitis.
• Always use the instrument in dried state.
Avoid rapid temperature change which may cause condensation.
Using the instrument on/in which condensation occurs or is spilled liquid, can cause electric
shock or short-circuiting.
Leave the instrument to stand for a while in the newly installed location to allow it to become
acclimated to the environment before switching it ON.
• DO NOT cover the vent.
The temperature get hot, there is a risk of short-circuitting or other accidents.
• Adjust the position and orientation of the monitor and operation panel by keeping a
sufficient distance between the instrument and the peripheral equipment, walls and people.
Contact with the monitor may result in injury or damage to the peripheral equipment, main
unit or touch panel.
Warn the doctor or patient before adjusting the position and orientation of the monitor.
If you adjusted the position or orientation of the monitor after the examination is started, warn
the patient and others and reset the position of the monitor to the home position after the
examination is completed.
• Perform regulary maintenance and inspection in this manual.
Components of the equipment has deteriorated due to years of use. Tere is a risk for degrading
its performance, braking down, emitting smoke or ignition. If you notice any problems, please
contact any of our office on back cover.
1-4
MN1-5670 rev.1
Page 13
1 Safety Precautions
1-2 Precautions for Use
Safety precautions about Power Plug and Cable
Use the power cable provided, and plug it directly into the wall receptacle (hospital grade).
Using the cables or adapters to extend or branch the power connection may cause a short
circuit, ground leakage or fire.
• DO NOT damage, modify or server 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.
Using the equipment with damaged cable or plug may cause a loose connection or fire.
Please contact any of our offices listed on the 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.
MN1-5670 rev.1
1-5
Page 14
1 Safety Precautions
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 1-21.
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
MN1-5670 rev.1
Page 15
1 Safety Precautions
1-2 Precautions for Use
Labels on Connectors and Connection Terminals
(1)
Probe connector and connector number (1 -4)
(1)
Foot switch connector
IPX8 : Protected against the effects of
continuance immersion in water
(indicated the optional foot switch).
(2)
Independent probe connecter (option)
(2)
(3)
USB connector
(3)
MN1-5670 rev.1
1-7
Page 16
1 Safety Precautions
1-2 Precautions for Use
Kinds of connectors
physiological signal
ECG
PCG
PCG
PULSE
DC-IN
TRANSDUCER
PATIENT
CONNECTION
ELECTRICALLY
ISOLATED
the
TRANSDUCER
PATIENT
CONNECTION
ELECTRICALLY
ISOLATED
ECG
for
ECG
PULSE
PULSE
DC-IN
ECG
PULSE
: Type BF Applied parts
Labels on the Rear of the Instrument
(1)
(2)
(1)
(3)
(3)
(NO LABEL) Japan only
Show
the
name
of
manufacturer and model,
and etc.
Equi-potential terminals
(4) Combined label :Warning sign and manufacturer
information
(2)
(4)
(4)Combined label
2010
This instrument complies with
Directive 93/42/EEC relating to
Medical Device.
Date of manufacture.
Number under the mark means the
manufacturing year.
Do not dispose the instrument as
general waste.
Comply with a local regulation.
Authorized representative
European community
in
the
Manufacturer
1-8
MN1-5670 rev.1
Page 17
1 Safety Precautions
1-2 Precautions for Use
Each marks on lable (4) means following;
Safety Warning sign.
Use the power cable provided, and plug it directly into the wall receptacle (hospital
Dangerous
grade).
Voltage
There is the risk of short circuiting or ground leakage.
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
MN1-5670 rev.1
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. .
1-9
Page 18
1 Safety Precautions
1-2 Precautions for Use
Follow the instruction manual to operate this instrument.
Follow the
If not avoided, may result in injury, property damage, or the equipments trouble.
instruction
manual
Labels for Handling and Moving Operation Panel and Monitor
The monitor and operation panel of the instrument can be moved in an extremely wide range.
Adjusting the position of the monitor and operation panel or moving the instrument may cause
the instrument to hit the patient or others, as well as peripheral devices, hospital equipment or
parts within the instrument. It also may cause people to pinch their hands in the monitor arm.
The following label indicates caution to avoid these risks.
(1)
(2)
(7)
(3)
(8)
(4)
(5)
(6)
(1)
• Follow the instruction manual (“Adjusting the Operation Panel”
on page 3-20) to adjust the position of the monitor.
You may pinch your fingers or hands. It may hit the people, main
unit, touch panel, peripheral devices, etc.
(2)
Follow the instruction manual (“Moving the Instrument” on page
3-9) to fix the operation panel and move the instrument.
Do not lift the instrument by grasping the handle of the operation
panel. There is a risk of the instrument breaking down.
(3)
• Follow the instruction manual (“Adjusting the Monitor” on
page 3-23) to adjust the position of the monitor.
When you adjust the position of the monitor holding the bottom of
operation panel by your hand, you may pinch your fingers or
hands.
1-10
MN1-5670 rev.1
Page 19
1 Safety Precautions
1-2 Precautions for Use
(4)
Follow the instruction manual (“Moving the
Instrument” on page 3-9) to fix the operation
panel and move the instrument.
(5)
Follow the instruction manual (“Caster” on page 3-11) to lock or
unlock the front casters.
(6)
Follow the instruction manual (“Adjusting the Height of the
Operation Panel” on page 3-20) to adjust the height of the
operation panel.
(7)
Follow the instruction manual (“Caster” on page 3-11) to lock or
unlock the rear casters. From left, locking, unlocking, and locking
of the swing lock pedal.
(8)
Follow the instruction manual (“Moving the Instrument” on page
3-9) to fix the operation panel and move the instrument.
Move the instrument by grasping the handle at the back of the
instrument.
(2)
(2)
(3)
(1)
(1)
on the equipment
• Position (1) in the above label is located at the both right and left sides. Both carry the
same message.
Be careful not to pinch your fingers or hands when changing the location or
orientation of the operation panel.
• Position (2) in the above label
Be careful not to pinch your fingers or hands when changing the location or
orientation of the operation panel.
• Position (3) in the above label
The monitor arm may shift and pinch your hands or fingers in the handle when moving
the instrument.
MN1-5670 rev.1
1-11
Page 20
1 Safety Precautions
1-2 Precautions for Use
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.
1-12
MN1-5670 rev.1
Page 21
1 Safety Precautions
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.
MN1-5670 rev.1
1-13
Page 22
1 Safety Precautions
1-2 Precautions for Use
1-2-5
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.
1-14
MN1-5670 rev.1
Page 23
1 Safety Precautions
1-2 Precautions for Use
1-2-6
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
•
Note that electromagnetic radiation from this instrument may cause the abnormal operation
on the other medical electrical instrument nearby. In this case, stop using such instrument
immediately.
Electromagnetic environment
For the purposes of preventing electromagnetic interference, this instrument is intended
for use in hospitals, research institutions and similar facilities.
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.
3)
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.
MN1-5670 rev.1
1-15
Page 24
1 Safety Precautions
1-3 Electromagnetic compatibility
1-3
Electromagnetic compatibility
The electromagnetic compatibility (EMC) of this device is in conformity with the IEC
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.
1-3-1
Guidance and manufacturer’s declaration
–electromagnetic emissions
The prosound F75 is intended for use in the electromagnetic environment specified below.The
customer or the user of the prosound F75 should assure that it is used in such an environment.
Emissions test
RF emissions
Compliance
Group 1
The prosound F75 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 F75 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
1-16
MN1-5670 rev.1
Page 25
1 Safety Precautions
1-3 Electromagnetic compatibility
1-3-2
Essential performance
The ultrasound diagnostic devices has confirmed not to affect the essential performance or
safety of the system in the testing of the electromagnetic immunity based on IEC60601-1-2:
Ed.3. For the description of each essential performance, refer to the specifications or chapter 2
Essential performance
contents
refer
Scan Area
Scanning range of B mode image
SCAN AREA switch (How to Use)
Marker
Scale marks (distance, time and flow velocity) display Screen display (section 3-5)
Velocity Range (PRF)
Display range (scale mark) of flow velocity in the VEL RANGE switch(How to Use)
Doppler image display
M cursor
D cursor
Detect the M mode and the baseline of the Doppler CURSOR switch(How to Use)
pattern of the Bmode image
Flow Area
Display in color on the Flow mode image
Image Frequency Select
Switch the transmitting/receiving frequencies of the Image Freq menu (How to Use)
probe of the B, D, M, Flow, THE, ExPHD(THE), CHE
or ExPHD(CHE) mode
Focus
Number of the focal point and each focal point FOCUS switch (How to Use)
position
Acoustic Power
Control the acoustic power
Screen display (section 3-5)
8. Acoustic output Safety Information
Acoustic Power switch (How to Use)
Frame Rate
Combination of Line Density for black & white and Frame Rate menu (How to Use)
color images, in the Flow or the Power Flow mode.
Sample Volume
Volume of the sample gate that extracts the signals SAMPLE VOLUME switch, and Sample
from the B mode image in the PW Doppler mode
Volume menu (How to Use)
Image Select(D)
Image quality setting of Doppler spectrum image
Image Select (D) menu (How to Use)
Average (Flow)
Number of transmissions used to display blood flow
Average (Flow) menu, Preset: Flow, Power
Flow, eFlow, Tissue Flow, Tissue Power Flow
(How to Use)
Image Select(Flow)
Image quality setting of color image on the Flow mode Image Select (Flow) menu
and Power Flow mode
(How to Use)
Puncture
Display Puncture Guideline
Message
Warning messages indicating the correct method of 4. Message
operation, and an alarm tone.
Angle Correction
Correct the flow velocity value corresponding to the Angle Correct switch, Angle Correct menu,
angle of incidence of the Doppler beam
Preset : Doppler, Tissue Doppler (How to Use)
Heart Rate Display
Compute and display the heart rate from detected Display of physiological signals, Physio menu,
R-wave(HR***)
Preset : Physio(How to Use)
MN1-5670 rev.1
Pucture menu, Preset: Graphics (How to Use)
1-17