ssd-900_manual_rev_10.pdf
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MN1-0921 Rev.10
ULTRASOUND DIAGNOSTIC
EQUIPMENT
SSD-900
Manual Number : MN1-0921
Rev.10
0123
ALOKA CO., LTD.
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MN1-0921 Rev.10
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MN1-0921 Rev.10
Safety alert symbols
Safety alert symbols
The four indications [Danger], [Warning], [Caution] and [Note] used on this equipment and in this instruction manual have the following meaning.
Danger
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
A warning message is inserted here.
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
A warning message is inserted here.
Caution
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
A caution message is inserted here.
Note
Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the equipment and also to ensure that it is used efficiently.
An explanatory text is inserted here.
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MN1-0921 Rev.10
CONTENTS
1. Precautions for Use
1-1.
1-2.
Purpose of Use .......................................................................................................................................... 1-1
1-1-1.
Precautions concerning acoustic power ................................................................................ 1-2
1-1-2.
Use with an ultrasound enhancing agent .............................................................................. 1-2
1-1-3.
Use with a general pharmaceutical ........................................................................................ 1-2
Classification .............................................................................................................................................. 1-3
1-2-1.
According to the type of protection against electric shock:................................................. 1-3
1-2-2.
According to the degree of protection against electric shock:............................................ 1-3
1-2-3.
According to the degree of protection against harmful ingress of water .......................... 1-3
1-2-4.
According to the degree of safety of application in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide .............................................. 1-3
1-2-5.
According to the mode of operation ....................................................................................... 1-4
1-2-6.
Electromagnetic compatibility .................................................................................................. 1-4
1-3.
Safety .......................................................................................................................................................... 1-5
1-4.
Environmental Conditions ........................................................................................................................ 1-6
1-4-1.
Working environment ................................................................................................................ 1-6
1-4-2.
Storage environment................................................................................................................. 1-6
1-5.
Power Requirements ................................................................................................................................ 1-7
1-6.
Electromagnetic compatibility.................................................................................................................. 1-8
1-6-1.
The prevention of electromagnetic wave disorders ............................................................. 1-8
1-6-2.
The guideline of electromagnetic compatibility..................................................................... 1-9
1-6-3.
Guidance and declaration directive concerning electromagnetic emission ................... 1-10
1-6-4.
Restrictions for use.................................................................................................................. 1-10
1-6-5.
Guidance and Declaration directive concerning electromagnetic immunity ................. 1-11
1-6-6.
Guidance and Declaration directive concerning electromagnetic immunity
(conduction RF and emission RF). ....................................................................................... 1-12
1-6-7.
Combined use with High frequency surgical equipment ................................................... 1-14
2. Meaning of Symbols, Indications and Terms
2-1.
Symbols and Indications .......................................................................................................................... 2-1
2-1-1.
Safety alert symbols.................................................................................................................. 2-1
2-1-2.
Other symbols and indications ................................................................................................ 2-2
2-2.
Meaning of Terms ..................................................................................................................................... 2-4
2-3.
Position of Labels ...................................................................................................................................... 2-5
3. Installation Method
3-1.
Environmental Conditions of Installation Location ............................................................................... 3-1
3-1-1.
Working environment ................................................................................................................ 3-1
3-1-2.
Installation location.................................................................................................................... 3-2
3-1-3.
Power source ............................................................................................................................. 3-2
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MN1-0921 Rev.10
3-2.
ESD prevention procedures ..................................................................................................................... 3-3
3-2-1.
3-3.
Installing the Equipment ........................................................................................................................... 3-4
3-3-1.
3-4.
Electro-static discharge (ESD) guidelines.............................................................................. 3-3
Installation procedure ................................................................................................................ 3-4
Connecting a Probe to the Equipment ................................................................................................... 3-5
3-4-1.
Method of connecting an electronic type probe ................................................................... 3-5
3-5.
Connecting Options to the Equipment.................................................................................................... 3-7
3-6.
Connecting to other devices ................................................................................................................... 3-8
4. Specifications and Name of Each Part
4-1.
Specifications.............................................................................................................................................. 4-1
4-2.
Name and Function of Each Part ............................................................................................................ 4-3
4-2-1.
Exterior drawing and name of each part ................................................................................ 4-3
4-2-2.
Operation panel.......................................................................................................................... 4-5
4-2-3.
Front panel ................................................................................................................................ 4-10
4-2-4.
Right side panel........................................................................................................................ 4-12
4-2-5.
Rear panel................................................................................................................................. 4-13
5. COMPOSITION
5-1.
Standard composition ............................................................................................................................... 5-1
5-2.
Options ........................................................................................................................................................ 5-2
5-2-1.
Peripheral equipment ................................................................................................................ 5-2
5-2-2.
Table of optional probes (EU nations) .................................................................................... 5-3
5-2-3.
Table of optional probes (Outside EU) ................................................................................... 5-5
6. Principle of Operation
6-1.
Principle of Operation................................................................................................................................ 6-1
7. Cleaning and Sterilizing
7-1.
7-2.
Method of Cleaning and Sterilizing the Equipment .............................................................................. 7-1
7-1-1.
Cleaning that is carried out at the end of each day .............................................................. 7-1
7-1-2.
Cleaning that must be carried out once a week.................................................................... 7-1
7-1-3.
Cleaning that is carried out as necessary after use ............................................................. 7-1
Cleaning and Sterilizing Conditions ........................................................................................................ 7-2
8. Preparations for Use
8-1.
Starting Inspection ..................................................................................................................................... 8-1
8-1-1.
External Inspection .................................................................................................................... 8-1
8-1-2.
Checking and Replacing Consumables ................................................................................. 8-1
8-1-3.
Cleaning, disinfecting and Sterilizing Probes ........................................................................ 8-1
8-1-4.
Operation check ......................................................................................................................... 8-2
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8-2.
Preparations for Use ................................................................................................................................. 8-3
8-2-1.
Withdrawing and retracting the operation panel................................................................... 8-3
9. Screen Display
9-1.
Character Display...................................................................................................................................... 9-1
9-1-1.
9-2.
Automatic display area ............................................................................................................. 9-2
Graphic Display ......................................................................................................................................... 9-4
10. Operation Method
10-1.
Method of Operating Switches .............................................................................................................. 10-1
10-2.
Examination in the B Mode.................................................................................................................. 10-32
10-2-1.
10-3.
10-3-1.
10-4.
Basic Operation Procedure.................................................................................................. 10-34
Brachy Therapy Guide Display ........................................................................................................... 10-35
10-4-1.
10-5.
Basic Operation Procedure.................................................................................................. 10-32
Examination in the B/M and Mode...................................................................................................... 10-34
Basic Operation Procedure.................................................................................................. 10-35
Actions to be taken when a defect is detected ................................................................................. 10-39
10-5-1.
Ensuring patient safety ......................................................................................................... 10-39
10-5-2.
Handling the instrument........................................................................................................ 10-39
11. USEFUL FUNCTIONS
11-1.
Recording Images ................................................................................................................................... 11-1
11-1-1.
11-2.
Menu.......................................................................................................................................................... 11-2
11-2-1.
11-3.
11-4.
Recording data to a printer or camera ................................................................................. 11-1
Example of operation procedure........................................................................................... 11-3
Preset ...................................................................................................................................................... 11-21
11-3-1.
Setting procedure .................................................................................................................. 11-22
11-3-2.
Common Preset..................................................................................................................... 11-23
11-3-3.
Registration procedure USER Preset ................................................................................ 11-49
Cine Memory and Store Memory........................................................................................................ 11-97
11-4-1.
Cine Memory .......................................................................................................................... 11-97
11-4-2.
Basic Operation Procedure.................................................................................................. 11-99
11-4-3.
Cine Loop Playback ............................................................................................................ 11-102
11-4-4.
Store Memory....................................................................................................................... 11-103
12. MEASUREMENT FUNCTION
12-1.
Details of Measurement ......................................................................................................................... 12-2
12-2.
Function for Presetting ........................................................................................................................... 12-3
12-2-1.
Allocation Function for MEASUREMENT menu and USER switch................................. 12-3
12-2-2.
Caliper Auto Off function ........................................................................................................ 12-3
12-2-3.
Measurement unit selection function.................................................................................... 12-3
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12-3.
Display precision of the measurement result ...................................................................................... 12-3
12-4.
Basic Operation Procedure for Measurement..................................................................................... 12-4
12-5.
12-4-1.
Method of selecting measurement using the MEASUREMENT switch .......................... 12-4
12-4-2.
Method of a selecting measurement using a caliper mark................................................12-4
12-4-3.
Using the USER switches....................................................................................................... 12-5
User’s Calculation Function ................................................................................................................... 12-6
12-5-1.
Meaning of User’s Calculation function ................................................................................ 12-6
12-5-2.
Setting User’s Calculation....................................................................................................... 12-7
12-5-3.
Basic Method of Using the Auto Trace Function ................................................................ 12-8
13. BASIC MEASUREMENTS
13-1.
B-mode Measurements........................................................................................................................... 13-1
13-2.
M-mode Measurements ........................................................................................................................ 13-13
13-3.
Stenotic Rate Calculations ................................................................................................................... 13-21
13-4.
Ratio Calculations .................................................................................................................................. 13-26
13-5.
HIST (histogram measurement) .......................................................................................................... 13-31
13-5-1.
Method of Measuring Histogram Measurement................................................................ 13-32
14. Obstetrical Calculations
14-1.
Processing flow up to the obstetrical report ....................................................................................... 14-2
14-2.
Obstetrical measurement items that are calculated and explanation.............................................. 14-3
14-3.
14-4.
14-2-1.
Measured section for each parameter.................................................................................. 14-4
14-2-2.
Obstetrical tables installed in the system ............................................................................. 14-6
14-2-3.
Fetal weight calculation items installed in the system...................................................... 14-10
14-2-4.
Ratio calculations (displayed in the report area) installed in the system ...................... 14-11
14-2-5.
Pregnancy history calculation ..............................................................................................14-12
14-2-6.
Calculation equations ............................................................................................................14-12
14-2-7.
Range tables for internal AFI (displayed in the report area) ........................................... 14-13
PRESET set-up ...................................................................................................................................... 14-14
14-3-1.
OB-Program (Obstetrical Measurement Program) ........................................................... 14-15
14-3-2.
Setting the OB Study ............................................................................................................. 14-18
14-3-3.
Setting the Contents of OB Measurement Program......................................................... 14-19
14-3-4.
Setting Report Display Type................................................................................................. 14-47
14-3-5.
Setting Report Printer............................................................................................................14-55
14-3-6.
Setting the Anatomy Check List .......................................................................................... 14-59
14-3-7.
Setting Others......................................................................................................................... 14-65
14-3-8.
Formed Comment Settings................................................................................................... 14-69
14-3-9.
Menu Control .......................................................................................................................... 14-72
Explanation of the measurement area ............................................................................................... 14-73
14-4-1.
Gestational age measurement............................................................................................. 14-78
14-4-2.
Fetal weight measurement ................................................................................................... 14-81
14-4-3.
Amniotic fluid index measurement ...................................................................................... 14-87
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14-5.
14-6.
14-4-4.
AF Pocket ............................................................................................................................... 14-90
14-4-5.
Measurements for twins or triplets...................................................................................... 14-91
14-4-6.
Fetal heart rate....................................................................................................................... 14-92
Explanation of the REPORT area....................................................................................................... 14-93
14-5-1.
Explanation of the report pages .......................................................................................... 14-94
14-5-2.
Explanation of the Edit Page ............................................................................................. 14-113
14-5-3.
Explanation of FUNC LIST................................................................................................. 14-115
Data in the fetal growth table inside the system............................................................................. 14-116
15. CARDIAC CALCULATIONS
15-1.
Process of cardiac function report ....................................................................................................... 15-2
15-2.
Explanation of measurement items and indexes ............................................................................... 15-3
15-3.
PRESET set-up (Cardio-Program and Menu Control) ...................................................................... 15-9
15-3-1.
Cardio-Program ..................................................................................................................... 15-10
15-3-2.
Setting with Select formula of MEASUREMENT Package ............................................. 15-12
15-3-3.
Setting the Select formula of Report .................................................................................. 15-17
15-3-4.
Formed Comment Settings .................................................................................................. 15-21
15-4.
Menu Control.......................................................................................................................................... 15-24
15-5.
Measurement Area................................................................................................................................ 15-25
15-5-1.
15-6.
15-7.
Explanation of the measurement area ............................................................................... 15-26
Measurement Procedure...................................................................................................................... 15-28
15-6-1.
Left ventricular measurements ............................................................................................ 15-28
15-6-2.
B-mode measurements ........................................................................................................ 15-54
15-6-3.
M-mode measurements........................................................................................................ 15-63
Report Area ............................................................................................................................................ 15-74
16. OTHER Measurements
16-1.
Slice Volume (volume measurement) .................................................................................................. 16-1
16-1-1.
16-2.
Method of Measuring Slice Volume...................................................................................... 16-2
Hip Joint Angle......................................................................................................................................... 16-5
16-2-1.
Measurement Position ............................................................................................................ 16-5
16-2-2.
Method of Performing Bone Angle Measurement .............................................................. 16-5
17. GYNECOLOGICAL MEASUREMENTS
17-1.
Creating the Gyenecology Report ........................................................................................................ 17-1
17-2.
Description of Computed Measurement Items and Each Index ...................................................... 17-2
17-3.
PRESET Setup (Gynecological Measurement Program and Menu Control) ................................ 17-3
17-3-1.
Gynecological Measurement Program................................................................................. 17-4
17-3-2.
Setting Select B Measurement Items................................................................................... 17-6
17-3-3.
Setting Select Report Function.............................................................................................. 17-7
17-3-4.
Setting Report Printer ............................................................................................................. 17-9
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17-4.
Measuring Uterus Size.......................................................................................................................... 17-13
17-5.
Measuring the Cervix Size ................................................................................................................... 17-16
17-6.
Endometrium Measurement................................................................................................................. 17-19
17-7.
Ovary Size Measurement ..................................................................................................................... 17-21
17-8.
Follicles Size Measurement ................................................................................................................. 17-23
17-9.
Report Display ........................................................................................................................................ 17-24
18. Urological Measurements
18-1.
Flow to Urology Report ........................................................................................................................... 18-1
18-2.
Explanation of measurement items and indexs .................................................................................. 18-2
18-3.
PRESET set-up (Urological measurement Program and Menu Control) ....................................... 18-3
18-3-1.
18-4.
PSA Volume Measurement .................................................................................................................. 18-11
18-4-1.
18-5.
Testicular Volume measurement procedure...................................................................... 18-18
Renal Volume Measurement ............................................................................................................... 18-20
18-8-1.
18-9.
Bladder Volume measurement procedure ......................................................................... 18-16
Testicular Volume Measurement......................................................................................................... 18-18
18-7-1.
18-8.
Seminal Vesicle measurement procedure ......................................................................... 18-14
Bladder Volume Measurement ............................................................................................................18-16
18-6-1.
18-7.
Operation procedure for PSA Volume measurement ...................................................... 18-11
Seminal Vesicle Measurement ............................................................................................................18-14
18-5-1.
18-6.
Urological Measurement Program......................................................................................... 18-4
Renal Volume measurement procedure ............................................................................ 18-20
Cortical Thickness Measurement ........................................................................................................ 18-22
18-9-1.
Cortical Thickness measurement procedure ..................................................................... 18-22
18-10. Adrenal Measurement........................................................................................................................... 18-23
18-10-1. Adrenal measurement procedure........................................................................................ 18-23
18-11. Report Display ........................................................................................................................................ 18-25
19. After Using the Equipment
19-1.
Switching OFF the Equipment ............................................................................................................... 19-1
19-1-1.
19-2.
19-3.
Procedure for switching OFF the equipment ....................................................................... 19-1
Cleaning the Equipment ......................................................................................................................... 19-1
19-2-1.
Cleaning that is carried out at the end of each day ............................................................ 19-1
19-2-2.
Cleaning that must be carried out once a week.................................................................. 19-2
19-2-3.
Cleaning that is carried out as necessary after use ........................................................... 19-2
State of the Equipment and Accessories ............................................................................................. 19-2
20. Storing the Equipment
20-1.
Preparations for Storing the Equipment ............................................................................................... 20-1
20-1-1.
20-2.
Storage preparation procedure.............................................................................................. 20-1
Storage Location and Environmental Conditions ...............................................................................20-2
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20-2-1.
Storage environment............................................................................................................... 20-2
21. Moving the Equipment
21-1.
Precaution for moving............................................................................................................................. 21-1
21-2. State of the Equipment and Accessories Before Moving the
Equipment 21-1
21-2-1.
21-3.
Moving preparation procedure .............................................................................................. 21-1
Inspection Before Re-use....................................................................................................................... 21-2
22. Safety Inspection
22-1.
22-2.
Maintenance and Inspection.................................................................................................................. 22-1
22-1-1.
Weekly inspection.................................................................................................................... 22-1
22-1-2.
Monthly inspection................................................................................................................... 22-1
22-1-3.
Issues that require caution about electrostatic discharge (ESD)..................................... 22-2
Safety Inspection ..................................................................................................................................... 22-3
22-2-1.
22-3.
Periodic Safety Inspection Procedure, and Measurement ............................................... 22-3
Checking the Measurement Accuracy ................................................................................................. 22-6
22-3-1.
Inspection method ................................................................................................................... 22-6
22-3-2.
Evaluation of results................................................................................................................ 22-6
22-3-3.
Inspection Procedure .............................................................................................................. 22-7
22-4.
Measurement Accuracy Inspection Data Sheet ................................................................................. 22-9
22-5.
ULTRASOUND DIAGNOSTIC EQUIPMENT Safety Inspection Data Sheet .............................. 22-11
23. Troubleshooting
23-1.
Messages ................................................................................................................................................. 23-2
23-1-1.
WARNING ............................................................................................................................... 23-2
23-1-2.
Assistance messages ............................................................................................................. 23-3
24. DISPOSAL the Equipment
24-1.
Precaution of disposal ............................................................................................................................ 24-1
25. Probe use and care
25-1.
25-2.
Application use......................................................................................................................................... 25-1
25-1-1.
Contra indication...................................................................................................................... 25-2
25-1-2.
Warnings................................................................................................................................... 25-2
Connecting a Probe to the Equipment ................................................................................................. 25-3
25-2-1.
25-3.
25-4.
Method of connecting an electronic type probe.................................................................. 25-3
About activating of probe .......................................................................................................................... 25-5
Usable probe .............................................................................................................................................. 25-6
25-4-1.
Use of probe ............................................................................................................................... 25-6
25-4-2.
Specifications ........................................................................................................................... 25-8
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MN1-0921 Rev.10
25-5.
25-4-3.
Clinical Measurement Accuracy ............................................................................................ 25-9
25-4-4.
Clinical Measurement Range ............................................................................................... 25-10
Handling and maintenance of probe................................................................................................... 25-11
25-5-1.
Caution about handling ......................................................................................................... 25-11
25-5-2.
Cleaning of probe................................................................................................................... 25-11
25-5-3.
Disinfection of probe.............................................................................................................. 25-11
25-5-4.
Sterilization of probe.............................................................................................................. 25-12
25-5-5.
Maintenance and Inspection ................................................................................................ 25-12
25-5-6.
Storage Location and Environmental Conditions.............................................................. 25-13
26. Acoustic Output Safety Information
26-1.
About acoustic output index ................................................................................................................... 26-1
26-1-1.
Mechanical index (MI) ............................................................................................................. 26-1
26-1-2.
Thermal index (TI).................................................................................................................... 26-1
26-2.
Ultrasound wave, interaction between vital tissues............................................................................ 26-3
26-3.
Possible Biological Effects ..................................................................................................................... 26-3
26-4.
26-3-1.
Mechanical effects ................................................................................................................... 26-3
26-3-2.
Thermal...................................................................................................................................... 26-4
Derivation and Meaning of MI/TI ........................................................................................................... 26-5
26-4-1. Introduction ............................................................................................................................................... 26-5
26-4-1.
Introduction ...............................................................................................................................26-5
26-4-2.
Mechanical index (MI) ............................................................................................................. 26-5
26-4-3.
Thermal index (MI)................................................................................................................... 26-6
26-5.
Setting condition influencing device output ......................................................................................... 26-8
26-6.
Recommendation on ALARA (As Low As Reasonably Achievable) ............................................... 26-9
26-7.
Default Setting ........................................................................................................................................ 26-10
26-8.
Reference................................................................................................................................................ 26-11
26-9.
Acoustic Output Tables......................................................................................................................... 26-12
26-9-1.
Acoustic Output Measurements .......................................................................................... 26-12
26-9-2.
The condensation codes which are used in Acoustic Output Tables ............................ 26-13
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1-1.Purpose of Use
1. PRECAUTIONS FOR USE
1-1.
Purpose of Use
This equipment is intended to be used by doctors and other qualified persons for performing slice diagnoses in the
following parts of the human body. Do not use it for any other applications.
• Thorax
• Abdomen
• Perineum and pelvis
• Lower limbs
• Back
• Upper limbs
• Head
• Cranial nerves
• Neck
Warning
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.
Caution
(1) The intened use of probe differs depending upon the type of probe.
Select a probe that meets your purpose of use..
(2) Probes come in a variety of shapes and sizes to suit different applications, so be sure to use the right
probe for each application.
If you use an unsuitable probe, you may cause injury to the patient.
(3) The probe can harm the human body.
Do not use it for any application that is not covered in the instruction manual of the probe.
This section consists of 14 pages.
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1-1.Purpose of Use
1-1-1. 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 heating 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 equipment,
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.
Caution
(1) Use as low an output as possible within reason.
(2) Scan the body for only as long as is necessary to make a diagnosis. Prolonged use can harm the human
body.
1-1-2. Use with an ultrasound enhancing agent
If you wish to use an ultrasound enhancing agent, be sure to use only a substance that has been approved for use as
an ultrasound enhancing agent.
Before using an enhancing agent, carefully read the instructions for using the enhancing agent and also any cautionary notes.
1-1-3. Use with a general pharmaceutical
If you perform an ultrasound examination after having the patient ingest a general pharmaceutical, the ultrasound
may affect the pharmacological effect of the pharmaceutical.
Before using a general pharmaceutical, carefully read the instructions for using the pharmaceutical and also any cautionary notes.
1-2
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1-2.Classification
1-2.
Classification
1-2-1. According to the type of protection against electric shock:
• Class I equipment
1-2-2. According to the degree of protection against electric shock:
• Type BF equipment
Classification
Probe
Type BF equipment
All probes
Table Classification according to degree of protection
[Remark]
Type BF refers to ultrasound diagnostic equipment that uses only ultrasound probes that are intended for applications
not involving direct contact with the heart.
1-2-3. According to the degree of protection against harmful ingress of water
• Ordinary equipment
Warning
The equipment is not protected in any way against water ingress, so do not use it in a place where there is a
possibility of water getting into it.
Take care not to spill liquid onto or into the equipment. This is because of the danger of electric shock. If you
do happen to spill liquid on the equipment, contact one of Aloka's sales offices or agents listed on the back
cover of this instruction manual.
1-2-4. According to the degree of safety of application in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide
• Equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or
nitrous oxide.
Danger
Do not use this equipment in a flammable atmosphere.
It may cause an explosion if used in such an atmosphere.
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1-2.Classification
1-2-5. According to the mode of operation
• Continuous operation
1-2-6. Electromagnetic compatibility
• The electromagnetic compatibility (EMC) of this device is in conformity with the IEC 60601-1-2 which is the
international standard for EMC with medical equipment.
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1-3.Safety
1-3.
Safety
Warning
Do not remodel or modify equipment.
Unexpected accident can take place.
Warning
Clean and disinfect a probe every time it is used.
Using contaminated probes may result in infection.
Warning
Wear medical gloves during inspection, and wash your hands after inspection; otherwise you may become
infected from patients.
Caution
Hold a probe tightly not to slip, especially when using ultrasound gel or others; otherwise, the probe may slip
out of your hands and hit a patient.
Avoid rapid temperature change which may cause condensation.
Avoid using where condensation exist.
Caution
Always use this in dried state. Condensation may appear when using from cold to warm places.
Use without proper care, then, can cause short-circuiting.
Caution
Use of an ultrasonic beam into the air without coating the probe with an ultrasound medium, may cause surface temperature to rise.
Before using, coat probe adequately with ultrasound gel.(*)
When probe is not in use even during an examination, freeze image.
In the event that the surface temperature feels abnormal, immediately stop using the probe, and contact our
office.
(*) When performing a puncture or a surgical operation, use ultrasound medium as described in the instruction manual for the probe.
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MN1-0921 Rev.10
1-4.Environmental Conditions
1-4.
Environmental Conditions
1-4-1. Working environment
This equipment is intended to be used under the following environmental conditions. Be sure to install it in an environment that satisfies these conditions.
1-4-1-1.
Working environment
Ambient temperature:
10 — 40°C
Relative humidity:
30 — 85%
Atmospheric pressure:
700 — 1060 hPa
Caution
The presence of electromagnetic waves may result in a mis-diagnosis or a breakdown of the equipment.
If the equipment is to be used near a motor (elevator, pump room, etc.), power transmission line or wireless
equipment, it is necessary to electrostatically shield it.
1-4-2. Storage environment
Store the equipment in an environment that satisfies the following conditions.
1-4-2-1.
Storage environment
Ambient temperature:
−10 — 50°C
Relative humidity:
10 — 90%
Atmospheric pressure:
700 — 1060 hPa
Avoid rapid temperature change which may cause condensation.
Avoid using where condensation exist.
Caution
Always use this in dried state. Condensation may appear when moving from cold to warm places.
Use without proper care, then, can cause short-circuiting.
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MN1-0921 Rev.10
1-5.Power Requirements
1-5.
Power Requirements
The power requirements for this equipment are as follows.
Power requirements
Unit
Rated supply voltages or voltage ranges
(100 V specifications)
100V
(115 V specifications)
120V
(200 — 240 V specifications)
200 — 240V
Rated frequency or rated frequency range
50/60Hz
Power input
300VA
Auxiliary mains socket outlets
570VA
Table Power requirements
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MN1-0921 Rev.10
1-6.Electromagnetic compatibility
1-6.
Electromagnetic compatibility
1-6-1. The prevention of electromagnetic wave disorders
This device meets IEC 60601-1-2 which is the international standard for EMC with medical equipment.
Medical devices are apt to emit electromagnetic waves or receive interference from electromagnetic waves.
The EMC standard prescribes the testing of electromagnetic wave interference in transmitting and receiving.
An electromagnetic wave transmit testing relates to electromagnetic wave interferences being transmitted from
devices that are tested.
The electromagnetic wave level that occurs from a device is called as "electromagnetic emission" and the tolerance
of a device for the electromagnetic wave interference from other device is called as "electromagnetic immunity.
Caution
(1) Install this equipment where the electromagnetic radiation does not affect.
Note that the electromagnetic radiation may cause the following phenomena on this equipment.
• Distortion in viewing monitor
• Noise on physiological signals
• Noise from loudspeaker
• Noise on image
(2) Position this equipment and its cables (e.g. probe cables, ECG cables, I/O cables, etc.) as far away as
possible from other medical electrical equipment.
(3) Note that electromagnetic radiation from this equipment may cause the abnormal operation on the other
medical electrical equipment nearby. In this case, stop using such equipment immediately.
(4) This equipment intended to use in hospitals and/or institutions in order to prevent the electromagnetic
interference.
Use this equipment in facilities equivalent to the hospital or institution.
Note that electromagnetic radiation from this equipment may cause the disturbance to the radio receiver,
TV set, etc.
Position this equipment as far away as possible from the radio receiver, TV set, and its cables and
antenna.
(5) Do not use the portable radio communication devices (e.g. cellular phone, cordless phone, radio transceiver, etc.) near this equipment.
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MN1-0921 Rev.10
1-6.Electromagnetic compatibility
1-6-2. The guideline of electromagnetic compatibility
Our ultrasound diagnostic devices have been confirmed that no electromagnetic waves against the electromagnetic
wave interference standard are emitted by testing. As an ultrasound diagnostic device receives radio frequency signals ( supersonic wave signals on a Radio Frequency), there is a possibility to receive the electromagnetic wave interference that occurs from electromagnetic wave sources.
As for the electromagnetic sources having possibility to generate electromagnetic wave disorders, there are medical
equipment, communication devices, and radio or television broadcasting antennas.
When cellular/mobile communication machinery such as cellular phones, transceivers, and amateur radio equipment
are used, there can be effects affecting the operations of this device.
The device should be placed apart from other electrical apparatuses (including medical use) as much as possible.
When other electric apparatuses are installed in the neighborhood of this device, confirm the following.
• Are there any adverse effects of the electromagnetic waves occurring from other equipment affecting to this
device ?
• Are there any adverse effects of the electromagnetic waves occurring from this device affecting to other
equipment ?
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MN1-0921 Rev.10
1-6.Electromagnetic compatibility
1-6-3. Guidance and declaration directive concerning electromagnetic emission
SSD-900 is intended to use in the electromagnetic environment which is specified in the following.
It is desirable for customers or users of SSD-900 to confirm that the SSD-900 is used in such a environment.
Emission testing
Conformity
Electromagnetic environment Guidance
CISPR11
RF emission
Group1
The SSD-900 uses RF energy only
for its internal functions.
Therefore, the RF emission is very
low and there is few possibility of
allowing interferences to other
electronic equipment in the
neighborhood.
CISPR11
RF emission
Class B
IEC 61000-3-2
Higher harmonic emission
Class A
IEC 61000-3-3
Power-supply variations/flickers emission
Conformity
The SSD-900 is suitable for using in
all buildings including general
residential housing and connecting
to the commercial under-voltage
power supply system directly which
is supplied to housing as home-use.
Table Guidance and declaration directive concerning electromagnetic emission
1-6-4. Restrictions for use
It is necessary for a doctor to examine whether any artifacts affect images or diagnoses with effect attributable to the
electromagnetic wave interference.
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MN1-0921 Rev.10
1-6.Electromagnetic compatibility
1-6-5. Guidance and Declaration directive concerning electromagnetic immunity
SSD-900 is intended to use in the electromagnetic environment which is specified in the following.
It is desirable for customer or users of SSD-900 to confirm that the SSD-900 is used in such environments.
Immunity
examination
IEC 60601Testing
level
Conformity level
IEC 61000-42Electrostatic
discharge (ESD)
± 6kV contact
± 8kV atomospheric
± 6kV contact
± 8kV atomospheric
It is desirable that the floor
material is made of wood,
concrete or ceramic tile.
If the floor is covered with
synthetic materials, it is desirable
that the relative humidity of these
is 30% at least.
IEC 61000-4-4
Electrical fast
transcient / burst
For Power supply line
± 2kV
For Input line ± 1kV
For Power supply line
± 2kV
For Input line ± 1kV
It is desirable that the quality of
electric power source is the same
as the standard business or
hospital environments.
IEC 61000-4-5
Surge
± 1kV
Differential mode
± 2kV
± 1kV
Differential mode
± 2kV
Common mode
Common mode
It is desirable that the quality of
electric power source is the same
as the standard business or
hospital environments.
< 5% UT
(>95% Fall in UT)
0.5 cycle interval
< 5% UT
(>95% Fall in UT)
0.5 cycle interval
< 40% UT
(>60% Fall in UT)
5 cycle interval
< 40% UT
(>60% Fall in UT)
5 cycle interval
< 70% UT
(>30% Fall in UT)
25 cycle interval
< 70% UT
(>30% Fall in UT)
25 cycle interval
< 5% UT
(>95% Fall in UT)
5 seconds
< 5% UT
(>95% Fall in UT)
5 seconds
3 A/m
3 A/m
IEC 61000-4-11
Voltage dip,
Short-time power
cut, and voltage
fluctuation on the
power supply input
line
IEC 61000-4-8
Power frequency
(50/60Hz) magnetic
field
Remarks
Electromagnetic environment
- Guidance
It is desirable that the quality of
electric power source is the same
as the standard business or
hospital environments.
When the user of SSD-900
demands continuous operations
even during the time of power cut,
it is recommendable that the
SSD-900 is supplied of power
either with an
uninterruptive power supply
or a battery.
It is desirable that the power
frequency magnetic field has
the same level of characteristic as
the general place such as the
standard business or hospital
environments.
UT is AC power supply voltage before applying a testing level.
Table Guidance and Declaration directive concerning electromagnetic immunity
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MN1-0921 Rev.10
1-6.Electromagnetic compatibility
1-6-6. Guidance and Declaration directive concerning electromagnetic immunity
(conduction RF and emission RF).
SSD-900 is intended to use in the electromagnetic environment which is specified in the following.
It is desirable for customers or users of SSD-900 to confirm that the SSD-900 is used in such an environment.
Immunity
examination
IEC 60601Testing
level
Conformity
level
Electromagnetic environment
- Guidance
Cellular and Mobile RF communication
equipment including cables shall not be used
close to the any parts of this SSD-900 within
the recommended separation distances
calculated by the equations corresponding to
the frequencies of those transmitters
IEC 61000-4-6
Conduction RF
IEC 61000-4-3
Emission RF
3 Vrms
150 kHz —80MHz
3 V/m
80MHz—2.5GHz
V1=3V
Recommended separation distances
E1=3 V/m
Here, P stands for the maximum output power
rating that expresses in watt (W) of the
transmitter by the transmitter manufacturing
company, and d is the recommended
separation distance expressed in meter (m).
The electric field strength from a
non-transitory RF transmitter shall be set at
lower than the conformity level in each
frequency bandwidth b as having been decided
by the spot electromagnetic investigation a.
As for the next symbol, it is displayed on the
device which generates
electromagnetic waves intentionally.
In the neighborhood of the device displaying
this symbol, interference may occur.
Table Guidance and Declaration directive concerning electromagnetic immunity
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MN1-0921 Rev.10
1-6.Electromagnetic compatibility
Remark1 Apply high frequency ranges in 80MHz and 800MHz.
Remark2 These guidances are not applicable in all circumstances.
As for the electromagnetic diffusion, it is influenced by reflection or absorption of buildings, substance, and
humans.
a
For example, it is not possible theoretically to estimate precisely field intensities from fixed transmitters of
wireless-telephone-base stations, such as Mobil radio, amateur radio, AM/FM radio and TV broadcast base
stations.
Consider a spot electromagnetic investigation to assess electromagnetic environment caused by a
non-transitory RF transmitter accurately.
When the field intensity measured at the place where SSD-900 is used is higher than the applied RF
conformity level mentioned above, it shall be monitored whether the SSD-900 operates normally.
When abnormal movement was confirmed, an investigation for the placement or installment of the SSD-900
may be necessary.
b For the outside of 150kHz —80MHz frequency bandwidth, it is desirable that the field intensity is less than
3V/m.
Table Guidance and Declaration directive concerning electromagnetic immunity
Recommended separation distance between cellular and mobile RF communication equipment and SSD-900.
SSD-900 is intended to use in the electromagnetic environment that RF interference is controlled.
Customers or users of SSD-900 can promote the prevention of EMI (Electromagnetic interference) by managing
the shortest distance between mobile RF communication equipment (a transmitter) and SSD-900 in the following
recommendation based on the maximum output of transmitter devices
The maximum
output power rating
of a transmitter (W)
The separation distances (m) based on the frequencies of transmitters
26MHz—80MHz
80MHz—800MHz
800MHz—2.5GHz
0.01
0.116
0.116
0.233
0.1
0.369
0.369
0.738
1
1.167
1.167
2.333
10
3.689
3.689
7.378
100
11.67
11.67
23.33
For a rated transmitter with its maximum output electricity not listed above, the recommended distance of d
expressed in meter (m) can be decided by the equation corresponding to the frequency of the transmitter.
The P in the equation is the rating of the maximum output electricity of a transmitter expressed in watt (W) by the
transmitter manufacturing supplier.
Remark1 Apply a high frequency band in separation distance for 80MHz and 800MHz.
Remark2 These guidelines are not applicable for all situations. As for the electromagnetic diffusion, it is
influenced by reflection or absorption of buildings, substance, and humans.
Table Recommended separation distance between cellular and mobile RF communication equipment and SSD-900.
1-13