Titan 2.4 User Guide Supplement P06816-01C

English

TITAN Ultrasound System User Guide Supplement

Deutsch

Safety (MDS/MDS Lite) ...1 Electrical Safety Classification ...1 Biological Safety ...2 Electromagnetic Compatibility (EMC) ...2 The ALARA Principle ...6 Guidelines for Reducing MI and TI ...6 Output Display ...8 Transducer Surface Temperatures ...9 Labeling Symbols ... 11

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Chapter 6: Safety Français

The following information is a supplement to the TITAN Ultrasound System User Guide. Please read the information before using the TITAN® high-resolution ultrasound system.

Safety (MDS/MDS Lite) Italiano

WARNING:

To avoid the risk of electric shock and fire hazard, a multiple portable socket outlet (MPSO) or extension cord should not be connected to the auxiliary mains socket outlets on the MDS and MDS Lite.

Ultrasound system powered from power supply from the power supply or part of the Mobile Docking System

Class II equipment

Ultrasound system not connected to the power supply (battery only)

Type BF applied parts

Ultrasound transducers

Type CF applied parts

ECG module/ECG leads

IPX-7 (watertight equipment)

Ultrasound transducers

Dansk

Class I equipment

Português

Electrical Safety Classification

Svenska

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Non AP/APG

Ultrasound system power supply, Mobile Docking System, and peripherals. Equipment is not suitable for use in the presence of flammable anaesthetics.

Biological Safety WARNING:

To avoid the risk of a burn hazard, do not use the transducer with high frequency surgical equipment. Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection.

Electromagnetic Compatibility (EMC) The ultrasound system has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices to IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. Caution:

Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions. It is possible that high levels of radiated or conducted radio-frequency electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or nearby radio-frequency sources, could result in performance disruption of the ultrasound system. Evidence of disruption may include image degradation or distortion, erratic readings, equipment ceasing to operate, or other incorrect functioning. If this occurs, survey the site to determine the source of disruption, and take the following actions to eliminate the source(s). • • • • • • • • • •

Turn equipment in the vicinity off and on to isolate disruptive equipment. Relocate or re-orient interfering equipment. Increase distance between interfering equipment and your ultrasound system. Manage use of frequencies close to ultrasound system frequencies. Remove devices that are highly susceptible to EMI. Lower power from internal sources within facility control (such as paging systems). Label devices susceptible to EMI. Educate clinical staff to recognize potential EMI-related problems. Eliminate or reduce EMI with technical solutions (such as shielding). Restrict use of personal communicators (cell phones, computers) in areas with devices susceptible to EMI. • Share relevant EMI information with others, particularly when evaluating new equipment purchases which may generate EMI. • Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.

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Caution:

Deutsch

To avoid the risk of increased electromagnetic emissions or decreased immunity, use only accessories and peripherals recommended by SonoSite. Connection of accessories and peripherals not recommended by SonoSite could result in malfunctioning of your ultrasound system or other medical electrical devices in the area. Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite.

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Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. Static shock is a discharge of the electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system. The following precautions can help reduce ESD: anti-static spray on carpets, anti-static spray on linoleum, and anti-static mats.

Manufacturer’s Declaration Français

Table 1 and Table 2 document the intended use environment and EMC compliance levels of the system. For maximum performance, ensure that the system is used in the environments described in this table. The system is intended for use in the electromagnetic environment specified below. Table 1: Manufacturer’s Declaration - Electromagnetic Emissions

RF emissions ClSPR 11

Group 1

The SonoSite ultrasound system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions ClSPR 11

Class A

The SonoSite ultrasound system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network which supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

Dansk

Electromagnetic Environment

Português

Compliance

Italiano

Emissions Test

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The system is intended for use in the electromagnetic environment specified below.

Table 2: Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment

Electrostatic Discharge (ESD) IEC 61000-4-2

2.0KV, 4.0KV, 6.0KV contact 2.0KV, 4.0KV, 8.0KV air

2.0KV, 4.0KV, 6.0KV contact 2.0KV, 4.0KV, 8.0KV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast Transient burst IEC 61000-4-4

2KV on the mains 1KV on signal lines

2KV on the mains 1KV on signal lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

0.5KV, 1.0KV, 2.0KV on AC power lines to ground 0.5KV, 1.0KV on AC power lines to lines

0.5KV, 1.0KV, 2.0KV on AC power lines to ground 0.5KV, 1.0KV on AC power lines to lines

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

>5% UT (>95% dip in UT ) for 0.5 cycle 40% UT (60% dip In UT ) for 5 cycles 70% UT (30% dip in UT ) for 25 cycles >5% UT (>95% dip In UT ) for 5s

>5% UT (>95% dip in UT ) for 0.5 cycle 40% UT (60% dip In UT ) for 5 cycles 70% UT (30% dip in UT ) for 25 cycles >5% UT (>95% dip In UT ) for 5s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SonoSite ultrasound system requires continued operation during power mains interruptions, it is recommended that the SonoSite ultrasound system be powered from an uninterruptible power supply or a battery.

Power Frequency Magnetic Field IEC 61000-4-8

3 A/m

3 A/m

If image distortion occurs, it may be necessary to position the SonoSite ultrasound system further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the Intended installation location to assure that it is sufficiently low.

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Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued) Compliance Level

Electromagnetic Environment

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

Portable and mobile RF communications equipment should be used no closer to any part of the SonoSite ultrasound system including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

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IEC 60601 Test Level

Deutsch

Immunity Test

Recommended Separation Distance d = 1,2 P Radiated RF IEC 61000-4-3

3 Vim 80 MHz to 2.5 GHz

3 V/m

Français

d = 1,2 P 80 MHz to 800 MHz

Italiano

d = 2,3 P 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Português

Field strengths from fixed RF transmitters, as determined by an electromagnetic Site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Dansk

(IEC 60417 No. 417-IEC-5140: “Source of non-ionizing radiation”)

Chapter 6: Safety

Svenska

Note: UT is the AC mains voltage prior to application of the test level. Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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a. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the SonoSite ultrasound system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SonoSite ultrasound system. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

The ALARA Principle The information below is excerpted and edited from the TITAN Ultrasound System User Guide. See the user guide for complete text.

Applying ALARA The system has been designed to ensure that temperature at the face of the transducer will not exceed the limits established in Section 42 of EN 60601-2-37: Particular requirement for the safety of ultrasound medical diagnostic and monitoring equipment. See “Transducer Surface Temperatures” on page 9. In the event of a device malfunction, there are redundant controls that limit transducer power. This is accomplished by an electrical design that limits both power supply current and voltage to the transducer.

Direct Controls The system does not exceed a spatial peak temporal average intensity (ISPTA) of 720 mW/cm2 for all imaging modes. The thermal index (TI) may exceed values greater than 1.0 on some transducers in some imaging modes. One may monitor both MI and TI values and adjust the controls to reduce these values. Even though the system does not exceed an MI of 1.0 for all exam types, MI is displayed in certain modes and one may use this information to mitigate the MI value. See “Guidelines for Reducing MI and TI” on page 6. Additionally, one means for meeting the ALARA principle is to set the MI or TI values to a low index value and then modifying this level until a satisfactory image or Doppler mode is obtained. For more information on MI and TI, see BS EN 60601-2-37:2001: Annex HH.

Guidelines for Reducing MI and TI The following are general guidelines for reducing MI or TI. If multiple parameters are given then the best results may be achieved by minimizing these parameters simultaneously. In some modes changing these parameters will not affect MI or TI. Changes to other parameters may also result in MI and TI reductions. Please note the ‘MI’ or ‘TI’ read out on the right side of the LCD screen.

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“↓” means to decrease or lower setting of parameter to reduce MI or TI. “↑” means to raise or increase setting of parameter to reduce MI or TI. When the indicated setting is blank, then no consistent way was determined to change MI or TI by that parameter.

Table 3: MI Deutsch

Transducer

Depth

C8 C11 C15

Español

C60 ↓

HST ICT

Français

↓

L25 L38

Table 4: TI (TIS, TIC, TIB)

Transducer

Box Width

C8

Box Height

Box Depth

PRF

Depth

↓

↑

PW Settings Optimize ↑ (Depth)

C15

↓

C60

↓

HST

↓

↑ (Depth)

ICT

↑

↑ (Depth)

↓

↓ ↓

↑ (Depth) High

↑ (Depth)

Dansk

L38

Português

↑ (Depth)

C11

L25

Italiano

Color Power Doppler Settings

High Low

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Output Display Mechanical and Thermal Indices Output Display Accuracy The accuracy result for the mechanical index (MI) is stated statistically. With 90% confidence, 90% of the measured MI values will be within +16% to –31% of the displayed MI value, or +0.2 of the displayed value, whichever value is larger. The accuracy result for the thermal index (TI) is stated statistically. With 90% confidence, 90% of the measured TI values will be within +26% to –50% of the displayed TI value, or +0.2 of the displayed value, whichever value is larger. The values equate to +1dB to –3dB. A displayed value of 0.0 for MI or TI means that the calculated estimate for the index is less than 0.05.

Factors that Contribute to Display Uncertainty The net uncertainty of the displayed indices is derived by combining the quantified uncertainty from three sources; measurement uncertainty, system and transducer variability, and engineering assumptions and approximations made when calculating the display values. Measurement errors of the acoustic parameters when taking the reference data are the major source of error that contributes to the display uncertainty. The measurement error is described in the section on Acoustic Measurement Precision and Uncertainty included in the system user guide. The displayed MI and TI values are based on calculations that use a set of acoustic output measurements that were made using a single reference ultrasound system with a single reference transducer that is representative of the population of transducers of that type. The reference system and transducer are chosen from a sample population of systems and transducers taken from early production units, and they are selected based on having an acoustic output that is representative of the nominal expected acoustic output for all transducer/system combinations that might occur. Of course every transducer/system combination has its own unique characteristic acoustic output, and will not match the nominal output on which the display estimates are based. This variability between systems and transducers introduces an error into displayed value. By doing acoustic output sampling testing during production, the amount of error introduced by the variability is bounded. The sampling testing ensures that the acoustic output of transducers and systems being manufactured stays within a specified range of the nominal acoustic output. Another source of error arises from the assumptions and approximations that are made when deriving the estimates for the display indices. Chief among these assumptions is that the acoustic output, and thus the derived display indices, are linearly correlated with the transmit drive voltage of the transducer. Generally, this assumption is very good, but it is not exact, and thus some error in the display can be attributed to the assumption of voltage linearity.

Related Guidance Documents • Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, 1997. • Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994. (A copy is included with each system.) • Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD2-2004.

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Español

Table 5, Table 6, and Table 7 list the measured surface temperature of transducers used on the SonoSite system. The temperatures were measured in accordance with EN 60601-2-37 section 42 where controls and settings were positioned to give maximum temperatures.

Deutsch

Transducer Surface Temperatures

English

• Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1993. • Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, NEMA UD3-2004. • Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH, BS EN 60601-2-37 reprinted at P05699.

Table 5: Transducer Surface Temperatures EN 60601-2-37 (External Use) C60

Temperature Limit

Standard

Measured temperature T° C

Measured temperature T° C

Measured temperature T° C

Allowed max. temperature T° C

42.3(a) 1, Test Method B (IEC 60601-2-37, Amendment 1)

4° C rise

1.1° C rise

8.5° C rise

10° C from initial TMM measurement.

42.3(a) 2 (IEC 60601-2-37, Amendment 1)

6.8° C rise

Temperature rise from ambient temperaturea of the test object (tissue mimicking material or TMM) to maximum temperature on the test object within 1 mm of the active surface of the transducer. 7.5° C rise

13.4° C rise

Português

27° C rise from ambient. Temperature rise from ambient temperatureb, as measured on the active surface of the transducer, over a 30 minute time period.

Dansk

a. b.

Italiano

C15

Français

C11

The ambient temperature shall be 23° C ± 3° C Ibid. Svenska

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Table 6: Transducer Surface Temperatures EN 60601-2-37 (External Use) HST

L25

L38

Temperature Limit

Standard

Measured temperature T° C

Measured temperature T° C

Measured temperature T° C

Allowed max. temperature T° C

42.3(a) 1, Test Method B (IEC 60601-2-37, Amendment 1)

1.1° C rise

0.6° C rise

4.2° C rise

10° C from initial TMM measurement.

42.3(a) 2 (IEC 60601-2-37, Amendment 1)

2.7° C rise

a. b.

10

Temperature rise from ambient temperaturea of the test object (tissue mimicking material or TMM) to maximum temperature on the test object within 1 mm of the active surface of the transducer. 9.8° C rise

The ambient temperature shall be 23° C ± 3° C Ibid.

Chapter 6: Safety

6.8° C rise

27° C rise from ambient. Temperature rise from ambient temperatureb, as measured on the active surface of the transducer, over a 30 minute time period.

English

Table 7: Transducer Surface Temperatures IEC 60601-2-37 (Internal Use)

Standard

Measured temperature T° C

Measured temperature T° C

Allowed max. temperature T° C

42.3(a) 1, Test Method B (IEC 60601-2-37, Amendment 1)

1.1° C rise

3.3° C rise

6° C from initial TMM measurement.

42.3(a) 2 (IEC 60601-2-37, Amendment 1)

7.7° C rise

7.3° C rise

27° C rise from ambient Temperature rise from ambient temperatureb, as measured on the active surface of the transducer, over a 30 minute time period.

Italiano

a. b.

Temperature rise from ambient temperaturea of the test object (tissue mimicking material or TMM) to maximum temperature on the test object within 1 mm of the active surface of the transducer.

Français

Temperature Limit

Español

ICT

Deutsch

C8

The ambient temperature shall be 23° C ± 3° C Ibid.

Labeling Symbols Português

Table 8: Labeling Symbols Symbol

Definition Device complies with relevant Australian regulations for electronic devices.

Dansk

Device complies with relevant Brazilian regulations for electro-medical devices.

Device complies with relevant FCC regulations for electronic devices. Svenska

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P06816-01