SSD-α10 Manual number 1 MN1-5205 Rev 18 Sept 2004

MN1-5205 Rev.18

VS-FlexGrid Pro Copyright(C)1999 Videosoft Corporation Portions of this software are based in part on the work of the Independent JPEG Group.

MN1-5205 Rev.18 Safety alert symbols

Safety alert symbols The four indications [Danger], [Warning], [Caution] and [Note] used on this instrument 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 instrument and also to ensure that it is used efficiently. An explanatory text is inserted here.

Classification of SSD-α10 • Protection against electric shock: Class I medical electrical equipment • Applied parts:Type BF applied parts • Protection against defibrillator emissions: Not compatible with defibrillator-proof applied parts • Protection against harmful ingress of water or particulate matter: Ordinary protection (IPX0) • Level of safety for use in air and flammable anesthetic gas, or in oxygen/nitrous oxide and flammable anesthetic gas: This instrument is not suitable for use in air and flammable anesthetic gas, or in oxygen/nitrous oxide and flammable anesthetic gas. • Operation mode: Continuous operation

1

MN1-5205 Rev.18

CONTENTS This book consists of two separate volumes. These two volumes have the same table of contents and the index respectively.

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 contrast agent ... 1-2

1-1-3.

Use with a general pharmaceutical ... 1-2

1-1-4.

Use with Other Medical Devices ... 1-3

Classification... 1-4 1-2-1.

According to the type of protection against electric shock:... 1-4

1-2-2.

According to the degree of protection against electric shock: ... 1-4

1-2-3.

According to the degree of protection against harmful ingress of water ... 1-4

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 oxide1-4 1-2-5.

According to the mode of operation... 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 and moving / transport environment... 1-6

1-5.

Power Requirements ... 1-7

1-6.

Electromagnetic compatibility ... 1-8

1-7.

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 ... 1-9

1-6-4.

Restrictions for use... 1-10

1-6-5.

Essential performance ... 1-10

1-6-6.

Guidance and Declaration directive concerning electromagnetic immunity ... 1-12

1-6-7.

Guidance and Declaration directive concerning electromagnetic immunity (conduction RF and emission RF)... 1-13

Safety Instructions for Connecting Network Devices... 1-15 1-7-1.

1-8.

Electrical safety Instructions for Connecting Network Devices ... 1-15

Other precautions ... 1-15

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

2

MN1-5205 Rev.18

3. Installation Method 3-1.

3-2.

Environmental Conditions of Installation Location ... 3-1 3-1-1.

Working environment... 3-1

3-1-2.

ESD prevention procedures ... 3-2

3-1-3.

Installation location ... 3-3

3-1-4.

Power source... 3-3

Installing the Instrument... 3-4 3-2-1.

3-3.

Connecting a Probe to the Instrument ... 3-5 3-3-1.

3-4.

Method of connecting an electronic type probe ... 3-5

Connecting Options to the Instrument... 3-7 3-4-1.

3-5.

Installation procedure ... 3-4

Connecting the instrument to the physiological signal terminal ... 3-7

Connecting with Other instrument ... 3-9

4. Specifications and Name of Each Part 4-1.

Specifications... 4-1

4-2.

Name and Function of Each Part... 4-5 4-2-1.

Exterior drawing and name of each part... 4-5

4-2-2.

Front panel ... 4-7

4-2-3.

Rear panel ... 4-9

4-2-4.

Caster ... 4-10

4-2-5.

Viewing monitor... 4-11

4-2-6.

Physiological signal Connector ... 4-12

5. COMPOSITION 5-1.

Standard composition ... 5-1

5-2.

Options... 5-2 5-2-1.

Peripheral instrument... 5-2

5-2-2.

Table of optional probes (EU nations)... 5-5

5-2-3.

Table of optional probes (Outside EU)... 5-9

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 Instrument ... 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 must be carried out once a month... 7-2

7-1-4.

Cleaning that is carried out as necessary after use ... 7-2

Cleaning and Sterilizing Conditions... 7-4 3

MN1-5205 Rev.18

8. Preparations for Use 8-1.

8-2.

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

Preparations for Use... 8-2 8-2-1.

Adjusting the monitor ... 8-2

8-2-2.

Adjusting the height of the operation panel ... 8-5

8-2-3.

Adjusting the position of the operation panel ... 8-6

8-2-4.

Adjusting the Angle and Position of the Monitor ... 8-7

9. Screen Display 9-1.

Character Display... 9-1 9-1-1.

9-2.

Automatic display area... 9-2

Graphic Display ... 9-4

10. After Using the Instrument 10-1.

Switching OFF the Instrument... 10-1 10-1-1.

10-2.

10-3.

Procedure for switching OFF the instrument ... 10-1

Cleaning the Instrument ... 10-1 10-2-1.

Cleaning that is carried out at the end of each day ... 10-1

10-2-2.

Cleaning that must be carried out once a week... 10-2

10-2-3.

Cleaning that is carried out as necessary after use... 10-2

State of the Instrument and Accessories ... 10-2

11. Storing the Instrument 11-1.

Preparations for Storing the Instrument ... 11-1 11-1-1.

11-2.

Storage preparation procedure ... 11-1

Storage Location and Environmental Conditions ... 11-2 11-2-1.

Storage environment ... 11-2

12. Moving the Instrument 12-1. 12-2. Instrument

12-3.

Precaution for moving... 12-1 State of the Instrument and Accessories Before Moving the 12-1 12-2-1.

Moving preparation... 12-1

12-2-2.

Moving procedure ... 12-3

Inspection Before Re-use ... 12-3

13. Safety Inspection 4

MN1-5205 Rev.18

13-1.

13-2.

Maintenance and Inspection ... 13-1 13-1-1.

Weekly inspection ... 13-1

13-1-2.

Monthly inspection ... 13-1

13-1-3.

Issues that require caution about electrostatic discharge (ESD)... 13-2

Safety Inspection ... 13-3 13-2-1.

13-3.

Periodic Safety Inspection Procedure, and Measurement ... 13-3

Checking the Measurement Accuracy... 13-6 13-3-1.

Inspection method... 13-6

13-3-2.

Evaluation of results ... 13-7

13-3-3.

Inspection Procedure ... 13-8

13-4.

Measurement Accuracy Inspection Data Sheet ... 13-11

13-5.

ULTRASOUND DIAGNOSTIC INSTRUMENT Safety Inspection Data Sheet... 13-14

14. Troubleshooting 14-1.

Trouble list... 14-1

14-2.

Messages... 14-2 14-2-1.

Message ... 14-3

14-2-2.

Assistant Messages ... 14-9

15. DISPOSAL the Instrument 15-1.

Precaution of disposal... 15-1

15-2.

Disposal of Old Electrical & Electronic Instrument... 15-1

16. Probe use and care 16-1.

16-2.

Application use ... 16-1 16-1-1.

Contra indication ... 16-1

16-1-2.

Warnings... 16-1

16-1-3.

External Inspection ... 16-1

Connecting a Probe to the Instrument ... 16-2 16-2-1.

Method of connecting an electronic type probe ... 16-2

16-3.

About activating of probe ... 16-4

16-4.

Usable probe ... 16-5 16-4-1.

16-5.

Use of probe... 16-5

16-4-2.

Specifications... 16-7

16-4-3.

Clinical Measurement Accuracy... 16-10

16-4-4.

Clinical Measurement Range... 16-11

Handling and maintenance of probe... 16-13 16-5-1.

Caution about handling... 16-13

16-5-2.

Precautions for performing a puncture operation ... 16-14

16-5-3.

Cleaning of probe ... 16-15

16-5-4.

Disinfection of probe ... 16-15

5

MN1-5205 Rev.18

16-6.

16-5-5.

Sterilization of probe... 16-15

16-5-6.

Probe cover... 16-15

16-5-7.

Maintenance and Inspection... 16-15

Transesophageal Echocardiogram probe ... 16-16 16-6-1.

Temperature control System ... 16-16

16-6-2.

Monitoring Surface Temperature... 16-16

17. Acoustic Output Safety Information 17-1.

About acoustic output index ... 17-1 17-1-1.

Mechanical index (MI)... 17-1

17-1-2.

Thermal index (TI)... 17-1

17-2.

Ultrasound wave, interaction between vital tissues ... 17-3

17-3.

Possible Biological Effects ... 17-4

17-4.

17-3-1.

Mechanical effects ... 17-4

17-3-2.

Thermal ... 17-5

Derivation and Meaning of MI/TI ... 17-6 17-4-1.

Introduction ... 17-6

17-4-2.

Mechanical index (MI)... 17-6

17-4-3.

Thermal index (TI)... 17-7

17-5.

Setting condition influencing device output ... 17-9

17-6.

Recommendation on ALARA (As Low As Reasonably Achievable)... 17-10

17-7.

Default Setting ... 17-11

17-8.

Protocol for calculating the measurement uncertainties ... 17-12

17-9.

Reference ... 17-21

17-10. Acoustic Output Tables... 17-22 17-10-1. Acoustic Output Measurements ... 17-22 17-10-2. Convex Sector Probe... 17-25 17-10-3. Phased Array Sector Probe... 17-103 17-10-4. Linear Probe ... 17-175 17-10-5. Combination Probe... 17-247 17-10-6. 3D Probe... 17-260 17-10-7. Mechanical Radial Probe ... 17-278 17-10-8. Mechanical Annular Array Sector Probe ... 17-282 17-10-9. Independent Probe... 17-284 17-10-10.Ultrasonic Gastrovideo Scope... 17-288 17-10-11.Ultrasonic Bronchofiber videoscope... 17-324

6

MN1-5205 Rev.18 1-1.Purpose of Use

1. PRECAUTIONS FOR USE 1-1.

Purpose of Use This instrument 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. Do not use it for any other applications. • Thorax • Abdomen • Perineum and pelvis • Lower limbs • Back • Upper limbs • Head • Neck

Warning The acoustic power from this instrument exceeds the upper ophthalmological limit indicated in the U.S. FDA standards. DO NOT use this instrument for performing ultrasound diagnosis of the eyes.

Caution The intended use of probe differs depending upon the type of probe. Select a probe that meets your purpose of use. Do not use it for any application that is not covered in the instruction manual of the probe. The probe can harm the human body.

This section consists of 16 pages. 1-1

MN1-5205 Rev.18 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. Pro-sound SSD-α10 shows the dynamics of blood flow using the Ultrasound Doppler Method. 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 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.

Caution Minimize acoustic output power setting as low as possible within reason. Execute ultrasound scanning for only as long as it is necessary for diagnosis. Prolonged use can harm the human body.

1-1-2. Use 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.

Caution 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.

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

MN1-5205 Rev.18 1-1.Purpose of Use

1-1-4. Use with Other Medical Devices Combined use with High frequency surgical equipment When the device is used concomitantly with a high frequency surgical equipment,the device and the parts there of have not been equipped with any means to protect the patient from burn injury. The high frequency surgical equipment may apply an electromagnetic field and electric current of high frequency to the patient intentionally. With these radiated high frequencies, the device may be affected with interference when it is drawing monochrome or color images.

Caution (1) When a probe, examining operator's hands, and a puncture attachment are located on the path of high frequency electrical current, there may be incidents of the damage to the probe and the burn injuries of the patient or the examining operator. (2) As damage to an insulating membrane and burn injuries to the patient and examining operator may be caused by rough handling of the electrode needle, do not put an excessive force to the needle in puncture with using a puncture attachment guiding it properly. (3) Operate the device with caution paying attention to the positions of the counter electrode plates and the connecting cord against the probe. Use in conjunction with a cardiac defivrillator

Caution Do not use in conjunction with a cardiac defivrillator.

1-3

MN1-5205 Rev.18 1-2.Classification

1-2.

Classification

1-2-1. According to the type of protection against electric shock: • Class I instrument

1-2-2. According to the degree of protection against electric shock: • Type BF instrument Classification

Probe

Physiological signal

Type BF instrument

All probes

ECG lead, PULSE transducer, PCG microphone

Table Classification according to degree of protection [Remark] Type BF instrument refers to a component of the ultrasound diagnostic instrument, which is consisting of the ultrasound probe and ECG lead only and not used directly for a heart but applied indirectly from outside.

1-2-3. According to the degree of protection against harmful ingress of water • Ordinary instrument(IPX0)

Warning The instrument 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 instrument. This is because of the danger of electric shock. If you do happen to spill liquid on the instrument, 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 • Instrument 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 instrument in a flammable atmosphere. It may cause an explosion if used in such an atmosphere.

1-2-5. According to the mode of operation • Continuous operation

1-4

MN1-5205 Rev.18 1-3.Safety

1-3.

Safety Warning Do not disassemble or remodel this instrument. 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 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.

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.

1-5

MN1-5205 Rev.18 1-4.Environmental Conditions

1-4.

Environmental Conditions

1-4-1. Working environment This instrument 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 - 75%

Atmospheric pressure:

700 - 1060 hPa

Caution The presence of electromagnetic waves may result in a mis-diagnosis or a breakdown of the instrument. If the instrument is to be used near a motor (elevator, pump room, etc.), power transmission line or wireless instrument, it is necessary to electrostatically shield it.

1-4-2. Storage environment and moving / transport environment Store, move or transport the equipment in an environment that satisfies the following conditions.

1-4-2-1.

Storage environment and moving / transport 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.

1-6

MN1-5205 Rev.18 1-5.Power Requirements

1-5.

Power Requirements The power requirements for this instrument are as follows. Power requirements

Unit

Rated supply voltages or voltage ranges (100 - 120 V specifications)

100 - 120V

(200 - 240 V specifications)

200 - 240V

Rated frequency or rated frequency range

50/60Hz

Power input

1200VA

Auxiliary mains socket outlets

350VA

Table Power requirements

1-7

MN1-5205 Rev.18 1-6.Electromagnetic compatibility

1-6.

Electromagnetic compatibility

1-6-1. The prevention of electromagnetic wave disorders This device meets IEC60601-1-2:2001, Amendment 1 which is the international standard for EMC with medical instrument. 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 instrument where the electromagnetic radiation does not affect. Note that the electromagnetic radiation may cause the following phenomena on this instrument. • Distortion in viewing monitor • Noise on physiological signals • Noise from loudspeaker • Noise on image (2) 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. (3) 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. (4) This instrument intended to use in hospitals and/or institutions in order to prevent the electromagnetic interference. Use this instrument in facilities equivalent to the hospital or institution. Note that electromagnetic radiation from this instrument may cause the disturbance to the radio receiver, TV set, etc. Position this instrument 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 instrument. (6) If the AC line voltage to this instrument fluctuates, the instrument may lock-up. Shut off the instrument. Keep power switch off for 5 minutes. Then the instrument automatically shut itself off. After that, reboot the power.

1-8

MN1-5205 Rev.18 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 instrument, communication devices, and radio or television broadcasting antennas. When cellular/mobile communication machinery such as cellular phones, transceivers, and amateur radio instrument 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 instrument affecting to this device ? • Are there any adverse effects of the electromagnetic waves occurring from this device affecting to other instrument ?

1-6-3. Guidance and declaration directive concerning electromagnetic emission SSD-α10 is intended to use in the electromagnetic environment which is specified in the following. It is desirable for customers or users of SSD- α10 to confirm that the SSD- α10 is used in such a environment. Emission testing

Conformity

Electromagnetic environment Guidance

CISPR11 RF emission

Group1

The SSD-α10 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 instrument 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-α10 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

1-9

MN1-5205 Rev.18 1-6.Electromagnetic compatibility

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.

1-6-5. Essential performance The ultrasound diagnostic devices has confirmed not to afferct the essential performance (its absence or degadation would result in an unacceptable risk) or safety of the system in the testing of the electromagnetic immunity based on IEC60601-1-2:2001, Amendment 1. Essential performance

contents

reference

SCAN AREA

Scanning range of B mode image

SCAN AREA switch (How to Use)

Marker

Scale marks (distance, time and flow velocity) display

9. SCREEN DISPLAY

Velocity Range

Display range (scale mark) of flow velocity in the Doppler image display

VEL RANGE switch (How to Use)

M, D cursor

Detect the M mode and the baseline of the Doppler pattern of the Bmode image

CURSOR switch (How to Use)

Flow Area

Display in color on the Flow mode image

9. SCREEN DISPLAY

Image / Frequency

Switch the transmitting/receiving frequencies of the probe of the B, D, M, Flow, THE, ExPHD(THE), CHE or ExPHD(CHE) mode

Image Freq menu (How to Use)

Focus

Number of the focal point and each focal point position

FOCUS switch (How to Use)

Acoustic Power

Control the acoustic power

17.Acoustic Output Safety Information, ACOUSTIC POWER switch (How to Use)

Frame Rate

Combination of Line Density for black & white and color images, in the Flow or the Power Flow mode.

Frame Rate menu (How to Use)

Sample Volume

Volume of the sample gate that extracts the signals from the B mode image in the PW Doppler mode

Sample 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 and Power Flow mode

Image Select (Flow) menu (How to Use)

1-10

MN1-5205 Rev.18 1-6.Electromagnetic compatibility

Essential performance

contents

reference

Puncture

Display Puncture Guideline

Pucture menu Preset : Graphics (How to Use)

Message

Warning messages indicating the correct method of operation, and an alarm tone.

14. TROUBLESHOOTING

Angle Correction

Correct the flow velocity value corresponding to the angle of incidence of the Doppler beam

Angle Correct menu, Preset : Doppler1, 2, Tissue Doppler (How to Use)

Heart Rate Display

Compute and display the heart rate from detected R-wave (HR***)

Display of physiological signals, Physio menu, Preset : Physio (How to Use)

R-Wave Blink Mark

Display R-wave mark when R-wave is detected

Physiological signals, Preset : Physio (How to Use)

1-11

MN1-5205 Rev.18 1-6.Electromagnetic compatibility

1-6-6. Guidance and Declaration directive concerning electromagnetic immunity SSD- α10 is intended to use in the electromagnetic environment which is specified in the following. It is desirable for customer or users of SSD- α10 to confirm that the SSD- α10 is used in such environments. Immunity examination

IEC 60601Testing level

Conformity level

Electromagnetic environment - Guidance

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 transient / 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 line(s) to line(s) ± 2kV line(s) to earth

± 1kV line(s) to line(s) ± 2kV line(s) to earth

It is desirable that the quality of electric power source is the same as the standard business or hospital environments.

IEC 61000-4-11 Voltage dip, Short-time power cut, and voltage fluctuation on the power supply input line

< 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

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-α10 demands continuous operations even during the time of power cut, it is recommendable that the SSD-α10 is supplied of power either with an uninterruptive power supply or a battery.

< 5% UT (>95% Fall in UT) 5 seconds

< 5% UT (>95% Fall in UT) 5 seconds

3 A/m

3 A/m

IEC 61000-4-8 Power frequency (50/60Hz) magnetic field

Remarks

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

1-12