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Appendix D: Regulatory Supplement

Reporting Health or Safety Related Issues or Concerns

Should the need arise to report any safety or health related issues or concerns regarding the use of
Gammex products, contact Gammex directly or in the case of our European customers, contact our
Authorized European Representative. Gammex's Authorized European Representative is:

Modifications to Equipment

Interaction with Other Electrical Equipment

EMC Precautions

The instrument complies with IEC 60601-1-2, Electromagnetic Performance standards, and the
operator should ensure that it is used in such an environment.

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany

WARNING: No modifications may be made to this unit without the

expressed written consent of Gammex. Unauthorized changes may

present a risk to user or patients and will void the warranty.

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Содержание 1425B

Страница 1: ...Title Doppler 403TM Flow Phantom Model 1425B...

Страница 2: ...ed Gammex Inc reserves the right to make periodic modifications to this manual without obligation to notify any person or entity of such revision This guide is written for Model 1425B Doppler 403 Flow...

Страница 3: ...I device in accordance with the Medical Device Directive 93 42 EEC Annex VII Gammex Class I medical products are listed in Europe with the Competent Authority of Germany Health and Safety Instructions...

Страница 4: ...latest product information and product updates Document Conventions Bold typeface indicates a button name or something that the user must type Italicized typeface indicates the title of a manual a cro...

Страница 5: ...Transducer Integrity 16 Distance Measurement Accuracy 17 Lateral and Axial Resolution and Image Geometry 18 Gray Scale Display 20 Qualitative 20 Quantitative 21 Baseline Test 21 Subsequent Tests 21 D...

Страница 6: ...vi Contents This page is intentionally left blank...

Страница 7: ...ng modes and technology including a non adipose tissue B A value and frequency dependent attenuation As a flow phantom the Doppler 403 consists of a low echogenicity fluid flow system and an electroni...

Страница 8: ...E Gel The HE High Equivalence Gel is a patented tissue mimicking material that makes up the phantom background The HE Gel has the acoustic properties of human tissue with a sound speed of 1540 10 m s...

Страница 9: ...the water dam with distilled water to optimize transducer coupling Clean all scanning gel from the phantom s surface using distilled water and a soft fabric or paper towel following the instructions...

Страница 10: ...when flow controller pump is on On steady Operating in CONTINUOUS mode Blinking Operating in PULSE mode 4 On Off switch Activates pump in CONTINUOUS mode and provides power to flow controller pump Fi...

Страница 11: ...Transducer Holder User s Guide for complete instructions Scanning Using an Abdominal Transducer 1 Place abdominal transducer on scanning surface and adjust scanner s depth setting and gain controls to...

Страница 12: ...r flow to reach the selected rate 2 On the ultrasound system activate Color Velocity Imaging Mode 3 Select a color scheme that distinguishes flow towards the transducer positive flow from flow away fr...

Страница 13: ...Horizontal Vessel Obtained Using a Sector Transducer 6 Scan the diagonal vessel in the same scanning plane orientation used in step 4 Figure 2 4 Color Velocity Image of the Diagonal Vessel Obtained Us...

Страница 14: ...enerate another spectral Doppler signal as shown in Figure 2 6 Figure 2 5 Doppler Spectral Display of Horizontal Vessel Beam Steering Continuous Flow Observe the following in Figure 2 5 Flow direction...

Страница 15: ...tected The Doppler spectral display is used to indicate Doppler signal sensitivity For additional instructions for performing Doppler signal procedures refer to Scanning with Doppler Signals on page 8...

Страница 16: ...ssel for Color Flow Penetration Depth 5 Record the test result on the Doppler QC Test Data Sheet 6 If required repeat steps 1 5 at a range of flow rates from low to high Low Flow Sensitivity at Depth...

Страница 17: ...6 Record the results on the Doppler QC Test Data sheet 7 If required repeat steps 1 6 at a range of flow rates from low to high Directional Discrimination The Directional Discrimination test evaluates...

Страница 18: ...inside a tube from near zero at the wall to higher values inside the tube Refer to Appendix A Flow Velocity Accuracy on page 27 If the velocity profile inside the tube is parabolic then the peak veloc...

Страница 19: ...itioned on the far left side of the scanning surface In the diagonal vessel parabolic flow is achieved at all flow rates The diagonal vessel is approximately 30 longer than the horizontal vessel Refer...

Страница 20: ...olume cursor indicates the region in the imaged volume from which Doppler information is collected for analysis The Sample Gate Positioning test evaluates the accuracy of the cursor s location in the...

Страница 21: ...s possible a Set transmit power to maximum 100 b Adjust transmit focus to maximum depth or near maximum depth c Increase receiver gain 2 Record the transducer power focus and gain settings on the B Mo...

Страница 22: ...from the transducer surface and projecting onto the image Many labs use a graded assessment of the transducer when interpreting the results For example a No evidence of dropout b 1 or 2 slight shadows...

Страница 23: ...and Horizontal Distance Measurement Tests 2 Use the electronic calipers to measure the distance between any two vertical pin targets and record the measurement 3 Compare with the known 2 cm distance...

Страница 24: ...ound 1540 m s pin targets appear as sharp points and the 2 mm anechoic cylinder is clearly visible and highly resolved Figure 4 5 Lateral Resolution Quality Differences Due to Speed of Sound Settings...

Страница 25: ...roups at various depths 9 Scan the nearest cystic target group to assess image geometry Figure 4 9 Each target should be round with a clean black appearance and well defined edges Bright specular echo...

Страница 26: ...rray transducer and set the beamformer speed of sound to 1540 m s 2 Scan the phantom s gray scale targets Figure 5 1 a Observe the difference in gray levels among the three targets b Adjust the gain c...

Страница 27: ...from this test will be used for all subsequent quantitative gray scale display tests 1 On the ultrasound system select a linear array transducer and set the beamformer speed of sound to 1540 m s 2 Sca...

Страница 28: ...ation Figure 5 2 right 5 Note the gain values displayed by the ultrasound system 6 In the active image adjust the gain until the target gray level in the left image matches the background gray level i...

Страница 29: ...d in suspension Store the power supply and cord in the pouch provided Never store the power supply directly on the phantom as doing so could damage the scanning surface Weighing The phantom s backgrou...

Страница 30: ...Support Parts Accessories can be ordered from the Gammex Sales department Telephone 1 608 828 7000 Disposal and Recycling The phantom contains electrical components In some countries the disposal of...

Страница 31: ...ontal 1 diagonal Position cm 0 3 Horizontal 2 0 below scanning surface Diagonal From 2 0 below scanning surface at wall to 16 0 at 40 Inside diameter mm 0 2 5 0 Material density g cm3 1 01 Scanning su...

Страница 32: ...02 6 and 6 dB same as background Anechoic 0 05 Speed of sound m s 10 1540 Power Battery type Rechargeable Li Ion 14 8V Battery rating 2200 mA h minimum 35 5 W h Mains supply 100 240V AC Device input 1...

Страница 33: ...the velocity profile at the measurement location The volume flow rate can be represented by an average velocity vmean across the vessel area For circular vessels the calculation is where D is the ins...

Страница 34: ...e Doppler 403 Flow Phantom up to 122 cm s Mean and Maximum Velocity Calculations Many ultrasound systems display velocity estimates on the spectral display The notations TAMEAN and TAMAX are often use...

Страница 35: ...achieve fully developed parabolic flow is directly proportional to the speed and therefore to the flow rate Table 3 1 on page 13 provides the calculations for entrance length L to realize parabolic fl...

Страница 36: ...rapher It is important to understand that TAMEAN is the average velocity in the sample volume established both by the Doppler range gate and by the ultrasound beam width Because the sample volume may...

Страница 37: ...locity An important influence on estimated velocity is the Doppler angle which is established by the direction of the beam and the direction of reflectors over the beam In most situations an angle cor...

Страница 38: ...32 Appendix A Flow Velocity Accuracy Figure A 9 Beam Geometry and Displayed Velocity Vessel Depth Effect...

Страница 39: ...h than if the reception had been at the fundamental frequency One way in which image quality is improved using harmonics is through the reduction of reverberations and unwanted clutter Figure B 1 left...

Страница 40: ...penetration Figure B 3 Fundamental Imaging left and Harmonic Imaging right Figure B 4 shows the improved resolution seen in harmonic imaging of the phantom s pin targets nylon fibers The fibers appea...

Страница 41: ...e not accurate these features may not be represented consistently Ultrasound systems use special processing algorithms to translate the amplitude of echoes into brightness levels on the system display...

Страница 42: ...the information displayed may affect the interpretation of the ultrasound image Notice how the positions of the original brightness levels B Bo and B seen in Figure B 5 on page 35 have moved to B 1 Bo...

Страница 43: ...its Journal of Ultrasound in Medicine 14 pp 273 277 6 Hendrick W R 1995 Quality Control and Acceptance Testing In W R Hendrick S D L Hykes D E Starchman Ed Ultrasound Physics and Instrumentation 3rd E...

Страница 44: ...38 Appendix C Additional Reading This page is intentionally left blank...

Страница 45: ...setup and use of the of the phantom WARNING This symbol indicates a risk of electric shock WARNING This symbol indicates a hazard that could result in major injury or equipment damage CAUTION This sy...

Страница 46: ...Gammex s Authorized European Representative is Modifications to Equipment Interaction with Other Electrical Equipment EMC Precautions The instrument complies with IEC 60601 1 2 Electromagnetic Perform...

Страница 47: ...of the defect and d which are found to be defective by Seller upon Seller s examination Buyer shall pay all transportation charges Products manufactured by third parties must be returned to Seller wit...

Страница 48: ...RUSRUDWH HDGTXDUWHUV LVFRYHU ULYH 0LGGOHWRQ 86 VXQQXFOHDU FRP...

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