SSD-4000 Ultrasound Rev 16 Volume 1

Page 1

MN1-1173 Rev.16

ULTRASOUND DIAGNOSTIC

EQUIPMENT

SSD-4000

Manual Number : MN1-1173

Rev.16

0123

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MN1-1173 Rev.16

VS-FlexGrid Pro

Copyright(C)1999 Videosoft Corporation

Portions of this software are based in part on the work of the Independent JPEG Group.

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MN1-1173 Rev.16

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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MN1-1173 Rev.16

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 Equipment............................................................................................................................... 3-4

3-2-1.

3-3.

3-4.

Connecting a Probe to the Equipment .......................................................................................................... 3-5

3-3-1.

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

3-3-2.

Method of connecting a mechanical scanner................................................................................ 3-7

Connecting Options to the Equipment.......................................................................................................... 3-9

3-4-1.

3-5.

Installation procedure ................................................................................................................... 3-4

Connecting the equipment to the physiological signal terminal................................................... 3-9

Connecting to other devices ...................................................................................................................... 3-12

4. Specifications and Name of Each Part

4-1.

Specifications................................................................................................................................................ 4-1

4-2.

Name and Function of Each Part.................................................................................................................. 4-4

4-2-1.

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

4-2-2.

Front panel .................................................................................................................................... 4-6

4-2-3.

Right side panel ............................................................................................................................ 4-7

4-2-4.

Left side panel............................................................................................................................... 4-8

4-2-5.

Rear panel ..................................................................................................................................... 4-9

4-2-6.

Caster ............................................................................................................................................ 4-9

4-2-7.

Viewing monitor......................................................................................................................... 4-10

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).......................................................................................... 5-4

5-2-3.

Table of optional probes (Outside EU)......................................................................................... 5-7

6. Principle of Operation

6-1.

Principle of Operation .................................................................................................................................. 6-1

7. Cleaning and Sterilizing

7-1.

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

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MN1-1173 Rev.16

7-2.

Cleaning and Sterilizing Conditions ............................................................................................................ 7-2

8. Preparations for Use

8-1.

Starting Inspection ....................................................................................................................................... 8-1

8-1-1.

8-2.

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

9. Screen Display

9-1.

9-2.

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

9-1-1.

Automatic display area................................................................................................................. 9-2

9-1-2.

Character display in the text area ................................................................................................. 9-3

Graphic Display ........................................................................................................................................... 9-3

10. After Using the Equipment

10-1.

Switching OFF the Equipment................................................................................................................... 10-1

10-1-1.

10-2.

10-3.

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

Cleaning the Equipment............................................................................................................................. 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 Equipment and Accessories .................................................................................................... 10-2

11. Storing the Equipment

11-1.

Preparations for Storing the Equipment..................................................................................................... 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 Equipment

12-1.

Precaution for moving................................................................................................................................ 12-1

12-2.

State of the Equipment and Accessories Before Moving the Equipment .................................................. 12-1

12-2-1.

12-3.

Moving preparation procedure................................................................................................... 12-1

Inspection Before Re-use ........................................................................................................................... 12-2

13. Safety Inspection

13-1.

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

13-1-1.

Weekly inspection...................................................................................................................... 13-1

13-1-2.

Monthly inspection..................................................................................................................... 13-1

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MN1-1173 Rev.16

13-1-3.

13-2.

Safety Inspection ........................................................................................................................................ 13-3

13-2-1.

13-3.

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

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 EQUIPMENT 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 ................................................................................................................... 14-10

15. DISPOSAL the Equipment

15-1.

Precaution of disposal................................................................................................................................. 15-1

15-2.

Disposal of Old Electrical & Electronic Equipment .................................................................................. 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 Equipment ........................................................................................................ 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

16-5.

16-4-1.

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

16-5-5.

Sterilization of probe ................................................................................................................ 16-15

16-5-6.

Probe cover ............................................................................................................................... 16-15

16-5-7.

Maintenance and Inspection ..................................................................................................... 16-15

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MN1-1173 Rev.16

16-5-8.

16-6.

Storage Location and Environmental Conditions .................................................................... 16-16

Transesophageal Echocardiogram probe ................................................................................................. 16-17

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 ........................................................................................................................ 17-3

17-4.

17-3-1.

Mechanical effects ..................................................................................................................... 17-3

17-3-2.

Thermal ...................................................................................................................................... 17-4

Derivation and Meaning of MI/TI ............................................................................................................. 17-5

17-4-1.

Introduction ................................................................................................................................ 17-5

17-4-2.

Mechanical index (MI)............................................................................................................... 17-5

17-4-3.

Thermal index (TI)..................................................................................................................... 17-6

17-5.

Setting condition influencing device output .............................................................................................. 17-8

17-6.

Recommendation on ALARA (As Low As Reasonably Achievable)....................................................... 17-9

17-7.

Default Setting ......................................................................................................................................... 17-10

17-8.

Protocol for calculating the measurement uncertainties .......................................................................... 17-11

17-9.

Reference ................................................................................................................................................. 17-20

17-10. Acoustic Output Tables............................................................................................................................ 17-21

17-10-1. Acoustic Output Measurements ............................................................................................... 17-21

17-10-2. The condensation codes which are used in Acoustic Output Tables ....................................... 17-22

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MN1-1173 Rev.16

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 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 equipment exceeds the upper ophthalmological limit indicated in the U.S. FDA

standards.

DO NOT use this equipment 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 14 pages.

1-1

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MN1-1173 Rev.16

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-4000 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 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

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 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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MN1-1173 Rev.16

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

Physiological signal

Type BF equipment

All probes and scanners

ECG lead, PULSE transducer, PCG microphone

Table Classification according to degree of protection

[Remark]

Type BF equipment refers to a component of the ultrasound diagnostic equipment, 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 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.

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

• Continuous operation

1-3

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MN1-1173 Rev.16

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

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.

1-4

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MN1-1173 Rev.16

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 — 75%

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.

[Remark]

Mechanical scanner : Ambient temperature : 20 — 40°C

Please take more than 3minutes to start to use the scanner after turning the power switch on when Mechanical

scanners were connected to the system.

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.

[Remark]

Mechanical scanner : Ambient temperature : 0 — 50°C

Please take more than 3minutes to start to use the scanner after turning the power switch on when Mechanical

scanners were connected to the system.

1-5

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MN1-1173 Rev.16

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 — 120 V specifications)

100 — 120V

(200 — 240 V specifications)

200 — 240V

Rated frequency or rated frequency range

50/60Hz

Power input

1100VA

Auxiliary mains socket outlets

500VA

Table Power requirements

1-6

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MN1-1173 Rev.16

1-6.Electromagnetic compatibility

1-6.

Electromagnetic compatibility

1-6-1. The prevention of electromagnetic wave disorders

This device meets IEC 60601-1-2:2001 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.

(6) If the AC line voltage to this equipment fluctuates, the equipment may lock-up.

Shut off the equipment.

Keep power switch off for 5 minutes. Then the equipment automatically shut itself off.

After that, reboot the power.

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MN1-1173 Rev.16

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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MN1-1173 Rev.16

1-6.Electromagnetic compatibility

1-6-3. Guidance and declaration directive concerning electromagnetic emission

SSD-4000 is intended to use in the electromagnetic environment which is specified in the following.

It is desirable for customers or users of SSD- 4000 to confirm that the SSD- 4000 is used in such a

environment.

Emission testing

Conformity

Electromagnetic environment Guidance

CISPR11

RF emission

Group1

The SSD-4000 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-4000 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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MN1-1173 Rev.16

1-6.Electromagnetic compatibility

1-6-5. Guidance and Declaration directive concerning electromagnetic immunity

SSD- 4000 is intended to use in the electromagnetic environment which is specified in the following.

It is desirable for customer or users of SSD- 4000 to confirm that the SSD- 4000 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-4000

demands continuous operations

even during the time of power cut,

it is recommendable that the

SSD-4000 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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MN1-1173 Rev.16

1-6.Electromagnetic compatibility

1-6-6. Guidance and Declaration directive concerning electromagnetic immunity

(conduction RF and emission RF).

SSD-4000 is intended to use in the electromagnetic environment which is specified in the following.

It is desirable for customers or users of SSD-4000 to confirm that the SSD-4000 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-4000 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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MN1-1173 Rev.16

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-4000 is used is higher than the applied RF

conformity level mentioned above, it shall be monitored whether the SSD-4000 operates normally.

When abnormal movement was confirmed, an investigation for the placement or installment of the SSD-4000

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-4000.

SSD-4000 is intended to use in the electromagnetic environment that RF interference is controlled.

Customers or users of SSD-4000 can promote the prevention of EMI (Electromagnetic interference) by managing

the shortest distance between mobile RF communication equipment (a transmitter) and SSD-4000 in the

following recommendation based on the maximum output of transmitter devices

The maximum

output power rating

of a transmitter (W)

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

The separation distances (m) based on the frequencies of transmitters

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-4000.

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Page 21

MN1-1173 Rev.16

1-6.Electromagnetic compatibility

1-6-7. 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.

1-13

Page 22

MN1-1173 Rev.16

1-7.Safety Instructions for Connecting Network Devices

1-7.

Safety Instructions for Connecting Network Devices

1-7-1. Electrical safety Instructions for Connecting Network Devices

The electromagnetic compatibility (EMC) of this device is in conformity with the IEC 60601-1-2:2001 which is the

international standard for EMC with medical equipment.The following instructions are applicable, when connecting

network devices to the Ultrasound system.

The instructions are provided in order for the entire system with network devices to meet

IEC60601-1-1 Electrical Safety Standard.

[Remark]

Connecting to network equipment requires the optional DICOM library (SOP-4000-20B)

1-7-1-1.

Network Devices

All non-medical network devices connected to the Ultrasound system, including Hubs, Work Stations and Personal

Computers, must comply with IEC60950 standard and must be Class I device.

1-7-1-2.

Installation and Network Connections

(1)

Non-medical devices must be kept at least 1.5 meters away from a patient.

(2)

When connecting the Ultrasound system with Computer Devices located out side of the Ultrasound examination room, a separation device (Network Hub) must be used in-between.

1-7-2. Other precautions

Once you switch ON the ultrasound diagnostic equipment, do not switch it OFF again for 2 - 3 minutes. If you switch

OFF the equipment while it is starting up, the hard disk may break down.

A primary battery is used to maintain the unit in an operable condition. If the battery runs down, the clock on the

system is shown a wrong time. (In this case, the operation of the ultrasound diagnostic equipment is unaffected.)

If the above phenomenon occurs, the battery must be replaced, so contact your nearest Aloka branch to do this.

The equipment contains a primary battery (lithium battery), so when disposing of it conform to the “Laws Relating

to the Disposal and Cleaning of Waste”.

Connecting

connectors

Cable name

Maximum cable

length

LAN cable

connector

LAN cable: Straight (in case of hub-use), cross

(when connecting to PC directly)

20m

Caution

When a cable other than the specified or longer than the maximum length is used, the EMC characteristic of

this device may be influenced.

1-14

Page 23

MN1-1173 Rev.16

2-1.Symbols and Indications

2. MEANING OF SYMBOLS, INDICATIONS

AND TERMS

2-1.

Symbols and Indications

2-1-1. 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.

This section consists of 6 pages.

2-1

Page 24

MN1-1173 Rev.16

2-1.Symbols and Indications

2-1-2. Other symbols and indications

The following marks are used in this equipment and this instruction manual.

Symbol

Position

Meaning

Various places

Danger

Carefully read the pertinent items in this manual, and

handle the equipment with great care.

ANSI standard Z535.3

IEC60601-1, Attached table D

BS 5378 PART1, Appendix A

Left side panel

Be careful of explosion

Be careful of electric shock

Left side panel

Left side panel

ANSI standard Z535.3

BS 5378 PART1, Appendix A

Be careful of acoustic power

Type BF applied part

Type BF applied part

IEC60601-1, Attached table D

Indicates the ON position of the switch.

Power switch

IEC60417-5007

2-2

Page 25

MN1-1173 Rev.16

2-1.Symbols and Indications

Symbol

Position

Meaning

Indicates the OFF position of the switch.

Power switch

IEC60417-5008

Alternating current

Rear panel

IEC60417-5032

Equi-potential terminals

Main power unit

IEC60417-5021

Electrostatic discharge (ESD) symbol:

A symbol warning of no touching to the pins cropping

out.

When touching to the pins cropping out or nearing to

them, there can be of malfunction or breaking down of

the device by electrostatic discharge.

Various places

This mark indicates this product complies with Directive

93/42/EEC relating to Medical Device.

Left side panel

0123

IPX8

Foot switch

MP-2345B

MP-2614B

Protected against the effects of continuos immersion in

water

IEC60529

WEEE Marking

Left side panel

EN50419

2-3