background image

23

The system changeability

Changeability and accuracy of measurement

Possible operating conditions and testing numbers needed to obtain displayed result accuracy of the

diagnostic system

Whether the display accuracy depends on specific system combination, mode combination , probe

component and launch mode combination, or all of above

Algorithm accuracy of the system software used to calculate the MI/TI

Approximation engineering method used in real time computation

5.2.3.2 Differences between Actual and Displayed MI and TI

For many assumptions used in the process of measurement and calculation, actually they are
conservative. For most organizations path, high estimate is made in the measurement and calculation
process of tissue exposure intensity. For example, using attenuation coefficient 0.3dB cm

-1

MHz

-1

much lower than the actual human tissue attenuation coefficient, choosing conservative values of
tissue characteristic. Therefore, displayed MI and TI values should be relative information for
reference, they serve to indicate to the operator whether a particular setting of the system increases or
decreases the possibility of Thermal or Mechanical effect, used to help the operator be careful to use
ultrasonic diagnostic system and follow the ALARA principle, these values can not be equal to actual
values.

5.2.3.3 Uncertainty of Measurement

Sound pressure is the most basic data of sound field measurement, and other sound field parameters
can be deduced from sound pressure, so when analysing measurement uncertainty, only take sound
pressure for analysis and uncertainty of other parameters can be deduced from the sound pressure.
Measurement uncertainty mainly include repeated measurement uncertainty and the system
uncertainty, the system uncertainty is an order of magnitude higher than repeated measurement
uncertainty, so the main analysis is the system uncertainty.

Mainly decided by the following

factors:

1. The sensitivity of hydrophone:According to hydrophone calibration report provided by ONDA

company, the maximum allowable error of sound pressure for hydrophone is plus or minus 12%;

2. Scope: according to agilent DSO6502A specifications, its effect on the sound pressure is plus or

minus 2%;

3. Temperature: effect of the thermocouple on sound pressure error is plus or minus 4%;

Above all uncertainty components are not related, synthetic standard uncertainty of sound pressure
is :plus or minus 13%.

5.2.4 Operator Control Property

There are three types of operation control related to the generation of mechanical/thermal effect:
direct control and indirect control, receiver control. Qualified operator should try to cut down the
acoustic output in the premise of effective diagnostic images.
■ Direct control The direct control of the acoustic output of this system is adjusting voltage size. But

its maximum acoustic output shouldn't be more than displayed acoustic output limit in any modes.

■ Indirect control

The controls that indirectly affect output are many imaging parameters. These are operating modes,
frequency, focal point number/position, image depth and pulse repetition frequency (PRF)(By
adjusting the [Scale] of the toolbar).
The operating mode determines whether the ultrasound beam is scanning or non-scanning. Thermal
effect is closely connected to M Mode, PW Doppler and Color Mode.
Acoustic attenuation of tissue is directly related to transducer frequency.
The focal point number and position is related to active aperture of transducer and beam width.
For the pulse repetition frequency( PRF)(By adjusting the [Scale] of the toolbar), the higher the PRF,

Summary of Contents for CProbe

Page 1: ...Wireless Probe Type Ultrasound Scanner CProbe User s Guide Prescription Statement Caution Federal law restricts this device to sale by or on the order of a physician A 0...

Page 2: ...t 11 3 3 3 Data measurement 12 3 3 4 Report download 14 3 3 5image and vedio storage 15 3 3 5 1 Image storage 15 3 3 5 2 Vedio storage 16 3 3 6 Image and vedio review 16 3 3 7Replace the signal channe...

Page 3: ...22 5 2 4 Operator Control Property 23 5 2 5 Acoustic Power Settings 24 5 2 6 ALARA 24 5 3 Electromagnetic Compatibilities 24 5 3 1 Electromagnetic Emission 25 5 3 2 Electromagnetic Immunity 26 5 3 3...

Page 4: ...to be any iPad from Apple Inc or Apple iPhone The probe acts as a Wi Fi Access Point and can be connected by iPad or iPhone With the probe be connected through WiFi and the App is running enjoy your d...

Page 5: ...ng obstetrics OB gynecology GY and general abdominal imaging 1 4PRECAUTIONS WARNINGS PRECAUTION 1 Read the user manual carefully before operating the device be familiar with the equipment and operatio...

Page 6: ...ation Changes or Modifications not expressly approved by the party responsible could void the user s authority to operate this device This equipment has been tested and found to comply with the limits...

Page 7: ...which should be received with each particular system Table 2 1 Items List for The Wireless Ultrasound Scanner Each item should be examined for any noticeable defects or damage that may have occurred...

Page 8: ...e working status display display Product schematic diagram Picture 2 1 L probe Picture 2 2 C probe Picture 2 3 double head Wireless signal status display display Wireless signal status display display...

Page 9: ...ator lamp indicates the position of the convex array to work with the convex array probe and indicator linear array position to work with the linear array probe Charging support this probe only suppor...

Page 10: ...are installation please make sure your computer has installed the Apple iTunes And please copy the wireless scanner Application to the computer disk There are two separate applications one for IPAD an...

Page 11: ...5 2 Choose menu Add File to Library 3 Choose Application for IPAD or IPHONE confirm it...

Page 12: ...AD Enter into Apps menu the Apps option would appear the added application Choose Install the WirelessScan Application 5 Click Install the menu changes to Will Install choose Apply Startto install the...

Page 13: ...e cleaned and disinfected before and after ultrasound examination Please refer to chapter 4 Cleaning and Disinfection Caution Probes that have not been cleaned or disinfected may cause bacterial and v...

Page 14: ...by hold down the button for seconds When the probe is off the indicators will be turned off 2 4 WIRELESS CONNECTION When the probe is waiting for a wireless connection as described in previously laun...

Page 15: ...PW 9 Patient information management patient information input 10 Freeze operate image freeze and thaw 11 Movie playback replay after the image freezes 12 Measurement distance area obstetrical measurem...

Page 16: ...ove Zoom change the position and size of the color sampling frame by clicking and moving with your finger Picture 3 3 Energy Doppler imaging mode Energy Doppler imaging mode Picture 3 3 1 Color sampli...

Page 17: ...olume 5 Correction angle used to change the angle of the blood flow direction cursor 3 3 2 Patient information input Click on the software interface Patient Information thethe interface patient inform...

Page 18: ...n appear the heart rate can be measured and the default number of cardiac weeks is 5 weeks five segment that isfive heartbeat intervals are taken and the average heart rate is calculated Picture 3 7 M...

Page 19: ...them GA HC and GA AC are measured in the same way Select the ANGLE angle measurement function to measure the angle You can select the 3 o clock position to be measured in the frozen screen and click i...

Page 20: ...ment can be at most four sets of data After finish the measurement press the remove X can delete all measurements if you want to delete one measurement click measuring data result on the top right scr...

Page 21: ...loaded The report are stored automatically in the smart terminal display system apple mobile phone or tablet photo album figure 3 13 patient information download interface 3 3 5image and vedio storage...

Page 22: ...en the photo album of the smart terminal display system apple mobile phone or tablet then review the saved image and vedio 3 3 7Replace the signal channel In the WIFI crowded environment the user can...

Page 23: ...fully When charging completed please remove USB cable then insert rubber plug into the probe end to avoid liquid and damage the instrument Figure 4 1 Charge the Probe Caution If the adapter power supp...

Page 24: ...STORAGE When not in use it is recommended that the equipment should be put in the case While stored the equipment should be protected from temperature extremes 4 5TROUBLE SHOOTING Inspect check if th...

Page 25: ...art up again please wait at least 1 minute of time for boot operation 7 if instrument malfunction occur pls ask professional staff for maintenance 8 probes are valuble and vulnerable part any collisio...

Page 26: ...r repairs carried out by qualified technical personnel please contact us Please check and replace the battery periodically Warning Class I equipment to avoid the risk of electric shock the equipment m...

Page 27: ...ad or IPhone by wireless local network The software itself can not be connected to external network the network the software is connected to is the local wireless network launched by the probe During...

Page 28: ...That is the TI value informs the operator about the potential temperature rise in body tissue It is an estimate of temperature increase in body tissue with specific properties The actual amount of an...

Page 29: ...epeated measurement uncertainty and the system uncertainty the system uncertainty is an order of magnitude higher than repeated measurement uncertainty so the main analysis is the system uncertainty M...

Page 30: ...bioeffects are not generated while diagnostic information is being accumulated The total energy is controlled by output intensity and total radiation time The output intensity necessary for examinatio...

Page 31: ...mpliance Electromagnetic environment guidance 4 RF emissions CISPR 11 Group 1 The CProbe Wireless Probe Type Ultrasound Scanner uses RF energy only for its internal function Therefore its RF emissions...

Page 32: ...differential mode 2kV common mode 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage...

Page 33: ...mitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 5 3 V P 80 MHz to 800 MHz d 1 5 3 E P 800 MHz to 2 5 GHz d 1 7 E P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1...

Page 34: ...e of protection against electric shock Internally powered Degree of protection against electric shock Type BF applied part Operation mode Continuous working Installation and operation type Portable Eq...

Page 35: ...scan Aaprt 1 cm2 Aaprt 1 cm2 Maximum index value 0 65 0 16 N A Associated acoustic parameters pr 1 17 P 13 31 N A min of P Zs Ita Zs zs zbp zb z at max Ipi 4 70 deq Zb fawf 3 25 3 25 N A Dim of Aaprt...

Page 36: ...Aaprt X 1 29 1 29 1 29 N A Y 1 30 1 30 1 30 N A Other information td 0 73 prr 1250 pr at max Ipi 2 10 deq at max Ipi 0 62 Ipi at max MI 42 30 Focal Length FLx N A FLy 5 00 Operating control conditions...

Reviews: