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SAEVO EVUS 8 Owner's Manual

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English
OWNER´S
MANUAL
EVUS 8
Cód.:
77000001436
- Rev.:02

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Summary of Contents for SAEVO EVUS 8

  • Page 1 English OWNER´S MANUAL EVUS 8 Cód.: 77000001436 - Rev.:02...
  • Page 2 MANUAL PRESENTATION Technical Name: Ultrasound device Trade Name: Ultrasound Diagnostic Equipment Model: Evus 8 Brand: Saevo Responsável Técnico: Daniel R. de Camargo CREA-SP: 5062199650 ANVISA Registration nº: 10069210070 Alliage S/A Industrias Médico Odontológico Rodovia Abrão Assed, Km 53 - CEP 14097-500 Ribeirão Preto - SP - Brazil...
  • Page 3 Statement The manufacturer owns the intellectual property rights to this manual, and also maintains the contents of this manual as confidential information. This manual is a reference for the operation, maintenance and cleaning of this product and does not convey any license under the patent rights of the manufacturer, nor the rights of others. This manual contains the information protected by copyrights or patents.
  • Page 4 Item Meaning Click Move the cursor to the controls on the display and press the confirm key on the control panel. > Select a menu item or a key following the path.

  • Page 5: Table Of Contents

    Contents 1     S afety ��������������������������������������������������������������������������������������������������������������������������������������������������������������������� 1 Intended Use ................................1 Safety Precautions ................................ 1 1.2.1 Electrical Safety ............................... 1 1.2.2 Mechanical Safety ............................2 1.2.3 Accessories Caring ............................3 1.2.4 Biohazard Considerations ..........................3 Acoustic Power Principle ............................. 3 1.3.1 Biological Safety .............................. 4 1.3.2 ALARA ................................
  • Page 6 Contents 4.1.3 Storage Settings .............................. 27 4.1.4 Defined-Key Settings ............................. 28 Peripheral Device Settings ............................28 Defining Annotation Library ............................30 Body Mark Settings ..............................31 Measurement Settings ..............................31 4.5.1 General Measurement Settings ........................32 4.5.2 Application Settings ............................33 4.5.3 List Settings ..............................
  • Page 7 Contents 6.6.1 B+C/TDI +M..............................75 6.6.2 B + C/PDI/TDI + PW ............................. 76 6.6.3 B+C/PDI+CW ..............................77 7     E lastography Imaging ���������������������������������������������������������������������������������������������������������������������������������������� 79 Acquiring Elastography Images ..........................79 Optimizing Elastography Images ..........................80 7.2.1 Strain Map ..............................80 7.2.2 Strain Process ..............................80 7.2.3 Transparency ..............................
  • Page 8 Contents 10.5.2 Annotating an Image with Arrows ......................... 98 10.5.3 Body Mark ..............................98 10.5.4 Deleting Annotations and Body Marks ......................99 10.6 Using ECG ................................. 99 10.6.1 Basic Procedures of ECG Operation ......................100 10.6.2 Optimizing Parameters ..........................100 10.6.3 Reviewing ECG ............................
  • Page 9 Contents 14.2 Maintenance Checks ..............................128 14.3 Troubleshooting ............................... 129 14.4 Equipment Disposal ..............................129 14.5 Precautions for the Reduction of the Environment Impact ..................129 14.6 Precautions in Case of Destruction of the System ....................129 14.7 Customer Service ..............................130 Appendix ...
  • Page 10 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 11: Afety

    1     S afety This chapter describes the important information for operating this ultrasound system. To ensure the safety of both operator and patient, please read the relevant details in this chapter carefully before using this system. You should be thoroughly familiar with the precautions provided in this manual. Otherwise, the manufacturer is not responsible for the effects on safety, reliability and performance of the ultrasound system.

  • Page 12: Mechanical Safety

    1 Safety ● The video printer should be connected to the specific interface by using the cable provided by the manufacturer. Otherwise, electrical shock may occur. ● Within the environment that is 1.8 meters (6 feet) around a patient, connect peripherals to the auxiliary power outlet which is capable of isolation protection;...

  • Page 13: Accessories Caring

    1 Safety 1�2�3 Accessories Caring ● Do not use the foot switch in the operating room. ● Use the probe carefully. If any part of the transducer surface is scratched, stop using the probe immediately. Otherwise, electrical shock may occur. ●...

  • Page 14: Biological Safety

    1 Safety 1�3�1 Biological Safety Diagnostic ultrasound is recognized as being safe, but the possibility of biological effects exists when using it in high exposure levels and long exposure times. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.

  • Page 15: Probe Surface Temperature Limits

    1 Safety ■  MI/TI Display TI and MI values are displayed in the real time scan on the screen. The operator should observe these index values during examinations and ensure that exposure time and output values are maintained at the minimum amounts needed for effective diagnosis.
  • Page 16 1 Safety Symbol Meaning Protective earth (ground) Equipotentiality Alternating current Direct current Degree of IP protection Non-ionizing electromagnetic radiation. Manufacturer Date of manufacture Follow instructions for use Network port USB port Fragile AUDIO output Keep dry Maximum stacking limit of packages Maximum of two layers allowed for the system Keep this way upward Serial number...
  • Page 17 1 Safety Symbol Meaning Use it in ventilated and dry indoor environment (for power supply adapter only). Rechargeable (for battery only) This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
  • Page 18 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 19: Ystem Overview

    2     S ystem Overview This ultrasound system adopts advanced ultrasonic Doppler technologies. To ensure the performance and availability of this ultrasound system, you should be thoroughly familiar with the operations of system components, the control panel, the key panel and the basic screen. 2�1 System Configuration The standard system configuration mainly consists of the followings items:...

  • Page 20: Front Panel

    2 System Overview 2�3�1 Front Panel Figure 2-2 Front View LCD Monitor Control Panel Probe Holder Release Latch 2�3�2 Side View Figure 2-3 Side View Audio Output Port USB Port S-VIDEO Port VGA Video Output Port Network Port (DICOM) Power On/Off Button Basic User Manual...

  • Page 21: Rear Panel

    2 System Overview 2�3�3 Rear Panel Figure 2-4 Rear Panel Rating Label BNC Video Output Port Video Printer Port ECG Port Engineering USB Port AC Adapter Port Grounding Terminal Probe Port Foot switch Port 10 Probe Lock 2�3�4 Battery Compartment Figure 2-5 Battery Compartment View Dust Filter Battery Battery Lock...

  • Page 22: Control Panel

    2 System Overview 2�3�5 Control Panel Function key Key panel Controls Status indicator Figure 2-6 Control Panel ■  Function Key Name Description Five function keys are located below the selected item on the screen. ● Press it to select the corresponding menu item at the bottom of the screen. Function Key ●...
  • Page 23 2 System Overview Name Description Elastic Select it to enter or exit the elastography imaging mode. Invert Select it to enable or disable the flow invert in the Color mode or frequency spectrum invert in the PW/CW mode. Select it to enter the Harmonic Imaging mode in the real time mode. ■ ...
  • Page 24 2 System Overview Name Description ● Select it to activate the B mode. ● Rotate it to adjust the gain value in the B mode. ● Select it to activate the C mode. ● Rotate it to adjust the gain value in the C mode. Angle ●...

  • Page 25: Basic Screen

    2 System Overview Name Description Freeze Select it to freeze the image in the real time mode. Or, select it again to restore the real time scan. Use these 8 TGC sliders to adjust the gain value of the specific area on the image. ■ ...
  • Page 26 2 System Overview Logo 12 Depth Scale and Focal Position Institution Name 13 Cine Loop Icon (in frozen mode) Patient ID 14 Network Connection Status Probe Model/Exam Type 15 Image Parameters Patient Name 16 Imagining Area MI and TIS Indices 17 Cine Loop Status (in frozen mode) System Date and Time 18 THI/PHI Status...

  • Page 27: Reparing The System

    3     P reparing the System System preparation is necessary before using the ultrasound system. The preparation includes but is not limited to positioning and adjusting the system, connecting the probe and the peripheral devices. 3�1 Positioning the System  Leave at least 20cm at the back and both sides of the ultrasound system for ventilation. Otherwise, the temperature rise could cause failures.

  • Page 28: Assembling/Disassembling The Battery

    3 Preparing the System ● If the battery emits an odor or heat, is deformed or discolored, or appears abnormal during use, charging or storage, remove it and stop using it immediately. If you have any questions about the battery, please contact the manufacturer.

  • Page 29: Status Indicator

    3 Preparing the System Figure 3-1 Battery Assembly ■  To Disassemble the Battery Switch the battery lock on the bottom to the position, and take out the battery as shown in Figure 3-2. Figure 3-2 Battery Disassembly  3�2�4 Status Indicator The indications of each status indicator are shown in Table 3-1. Table 3-1 Status Indicator Status Indicator Mains Supply...

  • Page 30: Powering On/Off The System

    3 Preparing the System 3�3 Powering On/Off the System ● Do not power off the system during a system upgrade or a data transmission. ● An extra 30-60 seconds are needed for powering on the system if it is powered off in an abnormal way previously.

  • Page 31: Connecting The Peripheral Device

    3 Preparing the System ■  To disconnect the probe Switch the probe lock on the system or on the transducer extender to the position, and pull the probe connector out directly. 3�6 Connecting the Peripheral Device 3�6�1 Connecting the Foot Switch ● To avoid damaging the foot switch, do not place the foot switch on the ultrasound system. ●...

  • Page 32: Connecting The Usb Printer

    3 Preparing the System 2. Press OK on the control panel menu of the printer. to select Network Config, and then press OK to confirm. 3. Press to select TCP IP Config, and then press OK to confirm. 4. Press 5. Press to select Manual, and then press OK to confirm. 6.

  • Page 33: Ustomizing Your System

    4     C ustomizing Your System The System Settings menu allows you to specify general system settings, printing, measurement and calculation settings. You can also define shortcut keys. All your customized settings can remain even after rebooting the system. After the ultrasound system is powered on, the LCD monitor displays the available probe and the application mode screen as shown in Figure 4-1.

  • Page 34: General System Settings

    4 Customizing Your System 4�1 General System Settings You can make general system settings on the General, Display, Storage and KeyConfig tabs. 4�1�1 General Settings System Setting General General Display Storage KeyConfig Peripheral Hospital Name NEW SITE Comment Freeze Response Cine Bodymark Trackball Sensitivity Measure Language&Time Report...

  • Page 35: Display Settings

    4 Customizing Your System Item Description Caps Lock Enable or disable the capital letter feature. ● Set it to On, all the typed letters are capital. Pressing Shift + X can enter a lower-case letter. ● Set it to Off, all the typed letters are lowercase. Pressing Shift + X can enter a capital letter.
  • Page 36 4 Customizing Your System Item Description Color of ROI Set the color for the interest region box. Display Format Set the default display format for the M and PW/CW modes. Screen Saver Enable or disable the screen saver feature. Screen Saver Delay (min) Set the period to activate the screen saver.

  • Page 37: Storage Settings

    4 Customizing Your System 4�1�3 Storage Settings System Setting General Display KeyConfig Storage General Peripheral Clip Format Comment Still Format Bodymark One Key Store Measure Store Frame Amout Print & Store Region Image Area Report Image Share Service DICOM Store to UsbDisk Load Default About Save&Exit...

  • Page 38: Defined-Key Settings

    4 Customizing Your System 4�1�4 Defined-Key Settings System Setting Storage General Display KeyConfig General Peripheral [Save] [U1] [U2] Save Image Save Save Comment Print Image Image Bodymark Sent to Usb Cine Cine Dicom Send Volume Volume Measure Dicom Print Save Auto Response Save Auto Response Report Print...
  • Page 39 4 Customizing Your System System Setting Enable LocalNetwork Enable Wireless Network General Name State Level DHCP Static IP Peripheral Mr.Wu Conn IP Address Comment Netmask Bodymark Default Gateway Measure Advance Report DICOM AE Title DICOM Mac Address Load Default Connect Disconnect Ping IP Address About...

  • Page 40: Defining Annotation Library

    4 Customizing Your System Item Description Advance Click Advance to view the information of your current network, and make settings of your local network. Connect the wireless network as follows: 1. Click Refresh to display all wireless networks on the menu. 2.

  • Page 41: Body Mark Settings

    4 Customizing Your System 4�4 Body Mark Settings System Setting Bodaymark General Peripheral Application Selected Available Comment Application ABD Bodymark > Measure >> Report << DICOM < Load Default About Save&Exit Exit Load Default Figure 4-9 Body Mark Settings Menu 1. Select an exam type from the drop-down list beside Application. 2.

  • Page 42: General Measurement Settings

    4 Customizing Your System 4�5�1 General Measurement Settings System Setting General Application List General Peripheral General Result Position Comment Right Top Eastern Bodymark Medium Dual+Quad Right Bottom Cross Cursor Size Measure Measure Line Size Medium Right Top Report Dist. Dash Line Disp. Doppler Right Top Vel.

  • Page 43: Application Settings

    4 Customizing Your System ■  Result Position Item Description Set the position of the result box. Dual+Quad Doppler 4�5�2 Application Settings System Setting General General Application List Peripheral Application Comment Auto/Man Trace Shortcut Key Measurement Setting Num 1 CUA/AUA Bodymark Num 2 Add 1 week to EDD Measure Num 3...
  • Page 44 4 Customizing Your System Item Description CUA/AUA Set to display CUA or AUA on the measurement report. CUA stands for Composite Ultrasound Age and AUA stands for Average Ultrasound Age. Add 1 week to EDD Enable to add one week to EDD. Show EDD on screen Enable to display EDD in the measured result box.
  • Page 45 4 Customizing Your System GA Table Measurement Author Deviation -2SD/+2SD Meas -2SD Mean +2SD Unit Meas[mm] -2SD[w+d] Mean[w+d] +2SD[w+d] Save&Exit Exit Figure 4-12 GA Table Growth Table Measurement Author Deviation -2SD/+2SD Meas -2SD Mean +2SD Unit Age[w+d] -2SD[mm] Mean[mm] +2SD[mm] Save&Exit Exit Figure 4-13 Growth Table 3.

  • Page 46: List Settings

    4 Customizing Your System 4�5�3 List Settings System Setting Application List General General Application Abdomen Peripheral Caliper Calc Comment List Bodymark Color Doppler Measure Category Collection Measurement Report Default Liver Length Port.V. Height Width DICOM Gallbladder Pancreas Load Default Spleen Kidney About Renal A...

  • Page 47: Report Settings

    4 Customizing Your System 4. Click Reorder and adjust the sequence of the collection or measurement on the pop-up screen. 4�6 Report Settings System Setting Logo General Peripheral Operation LOGO Comment 170×60Pixel,bmp Bodymark 1×1 Measure Title/Font Report Title 1 Title Title 2 Subtitle DICOM...

  • Page 48: Configuring Dicom

    4 Customizing Your System After settings, you can click Preview to preview the report. Press the Freeze button on the control panel to exit. 4�7 Configuring DICOM 4�7�1 Storage Service Settings You can connect the ultrasound system to the DICOM storage server and adjust the relevant settings on the Store Service tab.

  • Page 49: Commitment Settings

    4 Customizing Your System Item Description Relate to CommitStore Select the desired DICOM commitment storage server to be associated with the DICOM storage server. Send After Every Tick this item and the system sends an image to the DICOM storage server every Image Stored time the image is saved.

  • Page 50: Dicom Worklist Settings

    4 Customizing Your System Item Description DICOM AE Title Set the Application Entity (AE) title of the DICOM commitment storage server. Port Number Set the port number of the DICOM commitment storage server. Connect Timeout(sec) Set the time limit for the network connection timeout. Repeat Count Set the number of repeated attempts for connecting to the DICOM commitment storage server.

  • Page 51: Mpps Settings

    4 Customizing Your System Item Description Remote HostName Enter the name of the DICOM worklist server. IP Address Set the IP address of the DICOM worklist server. Click Ping to test the connection. DICOM AE Title Set the Application Entity (AE) title of the DICOM worklist server. Port Number Set the port number of the DICOM worklist server.

  • Page 52: Print Service Settings

    4 Customizing Your System Item Description ● Select Append from the drop-down list beside Service List, input the relevant Service List parameters information and click Add to add a new server. ● Select any server from the drop-down list and click Delete to delete the server. Remote HostName Enter the name of the MPPS server.
  • Page 53 4 Customizing Your System System Setting Store C-Store Worklist MPPS Print General Peripheral Service List DicomPrint Delete Comment DicomPrint Bodymark Remote HostName DicomPrint Measure Report IP Address 192.168.254.104 Ping DICOM DICOM AE Title Echo Load Default Port Number Connect Timeout(sec) About Properties Save&Exit...

  • Page 54: Defining System Defaults

    4 Customizing Your System Item Description Color Set the color of the image. Film Size Set the film size. Min Density Set the minimum density level of the film. Film Destination Set the film destination. ● Set it to MAGAZINE, the image will be stored in a film magazine. ●...

  • Page 55: Viewing System Information

    4 Customizing Your System ■  To load system defaults 1. Click Load, select a setting name and then a dialogue box appears. 2. Type Y on the control panel to confirm and begin loading; Type N to cancel loading. Select Delete on the control panel to delete the system defaults. 3.

  • Page 56: Acoustic Output

    4 Customizing Your System 4�9�2 Acoustic Output You can view the acoustic output data of probes in different modes on the Acoustic Output tab. System Setting General General Acoustic Output Peripheral Register Type Comment Bodymark Probe Type Measure Report Exam Type DICOM Load Default About...

  • Page 57: Reparing For An Exam

    5     P reparing for an Exam You can start an exam without entering any patient information. To avoid patient identification errors, you should always verify the identification information with the patient. 5�1 Acquiring Patient Information You can acquire the patient information in the following ways: ●...
  • Page 58 5 Preparing for an Exam Patient ID Enter the patient ID, special characters are prohibited to be entered. The system will generate the patient ID automatically according to the current system time if this item is left blank. NOTE: The patient ID is an important identification, once it is saved, you cannot modify it. Name Enter first name, middle name or last name of the patient.

  • Page 59: Retrieving Archived Information

    5 Preparing for an Exam 4. Click OK to save the modifications. If the last patient exam is not completed, the system will remind you to complete or discontinue the exam. For details, refer to Section 5.3.2 Discontinuing an Exam. 5�1�2 Retrieving Archived Information You can retrieve the archived information by choosing the Patient key > Patient List > Exam Review.

  • Page 60: Using Dicom Worklist

    5 Preparing for an Exam Patient Exam List Patient ID Last Name Search Date First Name 05/04/2014 05/05/2014 Reset Patient Review Current Exam Patient ID Patient Name Birth Date Exam Date/Time Image Size 20140505 Mary Unknown 05/05/2014-16:04:03 40.82M New Patient DICOM Queue PPS Screen Import/Export...

  • Page 61: Discontinuing An Exam

    5 Preparing for an Exam Do you wish to end the current exam? Cancel 2. Click OK to end the exam. 5�3�2 Discontinuing an Exam 1. Select the Patient key on the control panel to enter the New Patient screen and then click Patient List to enter the Patient Exam List screen.
  • Page 62 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 63: Cquiring Images

    6     A cquiring Images You can acquire images by optimizing the relevant parameters for clinical diagnosis. 6�1 Selecting a Probe and an Exam Type Once the ultrasound system is started up, the LCD monitor displays the available probes and the exam types (as shown in Figure 6-1). You can select the desired probe by using the trackball. You can also select the Exam key to enter the application mode screen from other screens.
  • Page 64 6 Acquiring Images Going to User Pre-Set Menu Are you sure(Y/N)? 4. Select the Y key to enter the User preset screen, as shown in Figure 6-2. User preset menu Create preset Probe Presets display Exam Name ExamType < Vascular > ExamIcon C-Vascular <...

  • Page 65: Acquiring B-Mode Images

    6 Acquiring Images User preset menu Create preset Preset Exam: Presets display Cardiology(s) Liver(s) Granial(s) Difficult(s) new(u) Delete Restore Factory Default Exit Figure 6-3 Preset Display Screen ● Click one desired application preset, click to arrange the preset on the application mode screen. ●...

  • Page 66: Optimizing B-Mode Images

    6 Acquiring Images 6�2�2 Optimizing B-Mode Images After entering the B mode, the imaging parameters display at the bottom of the LCD monitor as shown in Figure 6-4, you can use them to optimize B-mode images. You can adjust other parameters and select display modes on the pop-up menu by selecting the Menu key. NOTE: You can adjust all parameters in the real time B mode, but can only adjust Chroma and GSC in the frozen B mode.
  • Page 67 6 Acquiring Images ■  Depth Depth is used to adjust the distance over which the B-Mode image is anatomized. To adjust the depth: ● Flip the DEPTH switch upwards to decrease the depth range of the 2D image and the size of image is magnified.
  • Page 68 6 Acquiring Images ■  Persistence Persistence is used to average consecutive frames to provide a smoother appearance with less noise. Use lower persistence values for fast-moving organs or tissues and higher persistence values for a smoother appearance. To adjust the persistence: 1.
  • Page 69 6 Acquiring Images 2. Select Power% by using the trackball or the ↑ or ↓ key. 3. Rotate the Menu key or select the ← or → key to increase or decrease the value. NOTE: Expose the patient to the lowest practical transmit power level for the shortest possible period of time to achieve a satisfactory diagnosis.

  • Page 70: Acquiring Color Flow Images

    6 Acquiring Images ■  Steer Steer can be adjusted to change the direction of the acoustic beam when performing a real time scan by using the linear probes. To adjust the steer: Flip the STEER switch to change the direction of the acoustic beam. NOTE: Only linear probes are capable of adjusting steer.

  • Page 71: Tdi Mode

    6 Acquiring Images A flow with slow velocity and small rate can be displayed in PDI. Therefore, a flow with a higher sensitivity can be detected without overlaying any flows with high velocity. The direction of flow, the flow velocity and flow properties cannot be reflected in the PDI-Mode image. Perform the following steps to acquire PDI-Mode images.

  • Page 72: Optimizing C/Pdi/Tdi Mode Images

    6 Acquiring Images cm/s 2 5 5 1 / 5 0 2D Imaging Color Flow ROI 2 . 2 Frequency C Map/DPDI B Reject Line Density Power% Sec.Width Sec.Pos Figure 6-7 TDI-Mode Imaging Screen 3. Adjust color flow ROI. − Move the trackball to position color flow ROI. −...
  • Page 73 6 Acquiring Images To adjust the wall filter: 1. Select WF by pressing the corresponding function key. 2. Rotate it to adjust the value. ■  Pulse Repetition Frequency Pulse repetition frequency is used to adjust the velocity scale. To adjust the pulse repetition frequency: ●...
  • Page 74 6 Acquiring Images To adjust the persistence: 1. Select the Menu key in the real time scan. A menu pops up on the screen. 2. Select Persist by using the trackball or the ↑ or ↓ key. 3. Rotate the Menu key or select the ← or → key to increase or decrease the value. ■ ...

  • Page 75: Acquiring M-Mode Images

    6 Acquiring Images When Flow Invert is set to Off, red pixels represent flow to the probe; blue pixels represent flow away from the probe. When Flow Invert is set to On, blue pixels represent flow to the probe; red pixels represent flow away from the probe.

  • Page 76: Anatomical M-Mode

    6 Acquiring Images Y axis: Frequency X axis: Time Figure 6-9 M-Mode Imaging Screen − X-axis is the time scale. − Y-axis is the depth scale. NOTE: Once the M mode is activated, you can move the trackball to stop the M trace and adjust the M line. The system continues tracing if the trackball is idle for more than 0.5s.

  • Page 77: Optimizing M-Mode Images

    6 Acquiring Images 4. Adjust the position and the angle of M line. − Position the desired M line by using the trackball. − Select the Set key on the control panel to select the desired M line. 5. Select the Update key on the control panel to activate the anatomical M-mode. NOTE: Once the anatomical M-mode is activated, anatomical M-mode imaging will display on the X-axis and Y-axis.

  • Page 78: Acquiring Spectral Doppler Images

    6 Acquiring Images To set the display format: 1. Select the Menu key in the real time scan. A menu pops up on the screen. 2. Select Dis Format by using the trackball or the ↑ or ↓ key. 3. Rotate the Menu key or select the ← or → key to adjust the setting. ■ ...
  • Page 79 6 Acquiring Images Spectral Doppler Line Flow Cursor Sample Volume Gate 2D Imaging Figure 6-11 Inactivated B+PW Mode 1 Imaging Screen − The spectral Doppler line and the sample volume gate are used to locate the qualitative analysis on the image. − The flow cursor needs to be adjusted parallel to the flow when measuring the velocity. 3.

  • Page 80: Cw Mode

    6 Acquiring Images 6. Optimize the PW-mode image. For details, refer to Section 6.5.3 Optimizing Spectral Doppler Images. If needed, select the Update key on the control panel to enter the inactivated B+PW mode 2, the following screen appears. cm/s Y-axis: Frequency X-axis: Time...
  • Page 81 6 Acquiring Images − Adjust the angle of the spectral Doppler line by moving the trackball left or right. 4. Rotate the Angle knob to increase or decrease the angle of the flow cursor. 5. Select the Update key to activate the CW mode. The CW spectrum is displayed at the lower part of the screen after being activated, as shown in Figure 6-15.

  • Page 82: Optimizing Spectral Doppler Images

    6 Acquiring Images cm/s Y-axis: Frequency X-axis: Time Figure 6-16 Inactivated B+CW Mode 2 Imaging Screen You can also adjust the position and angle of spectral Doppler line, and the direction of the flow cursor. 7. Select the CW key again to exit. 6�5�3 Optimizing Spectral Doppler Images After activating the PW/CW mode, the imaging parameters display at the bottom of the LCD monitor, you can use them to optimize PW/CW-mode images.
  • Page 83 6 Acquiring Images ■  High Pulse Repetition Frequency Once HPRF is enabled, besides the original sample volume gate, one or more sample volume gates appear at shallower positions on the 2D image. The unnecessary low frequency signal or the disturbances made by non-flow movements, such as breath, heart beat or sweeps of the probe will be filtered.
  • Page 84 6 Acquiring Images ■  Power Power is used to select the amount of ultrasound acoustic power produced by the probe. The adjustment range of the power is 30 % -100%, and ±10% can be adjusted each time. The real time value of the power is displayed in the image parameter area on the basic screen.

  • Page 85: Acquiring Triplex-Mode Images

    6 Acquiring Images ■  Angle Correction Angle correction is used to adjust the angle of the flow cursor in the PW mode. To set the angle correction: 1. Select the Menu key in the real time PW mode. A menu pops up on the screen. 2.

  • Page 86: B + C/Pdi/Tdi + Pw

    6 Acquiring Images 4. Select the Update key to activate the C+M/TDI+M mode. The M + color flow mode image is displayed at the lower part of the screen after being activated, as shown Figure 6-18. Y-axis: depth X-axis: time Figure 6-18 B+C/TDI +M-Mode Imaging Screen −...

  • Page 87: B+C/Pdi+Cw

    6 Acquiring Images − Rotate the Angle knob to increase or decrease the angle of the flow cursor. 5. Select the Update key to activate the PW mode. The PW spectrum is displayed at the lower part of the screen after being activated, as shown Figure 6-20. cm/s Y-axis: frequency...
  • Page 88 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 89: Lastography Imaging

    7     E lastography Imaging As an adjunct technique for clinical practice, the elastography determines if an area of tissue is hard or soft when compared with its surroundings. The elastography image displays a range of map shades from the softest tissue in the image to the stiffest in a given field of view.

  • Page 90: Optimizing Elastography Images

    7 Elastography Imaging Basic User Manual...

  • Page 91: Transparency

    7 Elastography Imaging 7�2�3 Transparency Transparency allows you to bring out the tissue behind the color data. To adjust the transparency: 1. Select the Menu key in the real time scan. A menu pops up on the screen. 2. Select Transparency by using the trackball or the ↑ or ↓ key. 3.
  • Page 92 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 93: Sing 3D

    8     U sing 3D 3D imaging allows you to see width, height and depth of the anatomical structure. 3D imaging can be performed by all probes, but the quality of the images is closely related to 2D imaging. 3D imaging mainly applies to obstetric, gynecologic and abdominal exams. 8�1 Acquiring 3D Images The following description uses 3D imaging performed with the VC6-2 probe as an example.

  • Page 94: Working With 3D Images

    8 Using 3D − If is highlighted, adjust the sample line by positioning the anchor with the trackball. 7. Select the Menu key and set User Mode, Render Mode, Image Quality, Sweep Angle or Stabilization in the pop-up menu. − Select User Mode, rotate the Menu key or press the ← or → key to select a user mode. −...

  • Page 95: Setting Display Format

    8 Using 3D Anchor View B View A C 3D View C 3D Image Figure 8-3 Cropping Review Screen You can select the Set or Update key to highlight and select the desired status icon. − If is highlighted, use the trackball to position the ROI. −...

  • Page 96: Setting Render Mode

    8 Using 3D NOTE: Only volume probes are capable of using this feature. 8�2�4 Setting Render Mode Surface, Skel and X-Ray can be set. ● Surface is used to display the contour of fetus. ● Skel is used to display the spinal column and skeleton of the fetus. ●...

  • Page 97: Moving/Rotating/Magnifying Images

    8 Using 3D NOTE: Selecting Undo Cut can restore the cutting by using Trace Cut. ■  Cropping reviews by the box You can crop 3D image by adjusting a box on the 3D image to remove irrelevant areas from the area of interest. This feature is suitable for cropping regular reviews. Perform the following steps to crop a review.

  • Page 98: Optimizing 3D Image

    8 Using 3D ■  To move images  1. Select Move L-R or Move U-D by pressing the corresponding function key. 2. Rotate this function key to move the images. You can also use the ↑, ↓, ← or → key to move three sectional planes and the image. ■ ...

  • Page 99: Setting The Scan Mode

    8 Using 3D Perform the following steps to observe a review. 1. Select the menu item of Multi-Slice and rotate the Menu key or select the ← or → key to chose one slice. After selection, the slice on the corresponding axis is displayed on the screen. 2.

  • Page 100: Restoring The Image

    8 Using 3D ● If Scan Mode is set to Sector, you can adjust the sweep angle when performing the scan by the probe. Select the menu item of Z Angle and rotate the Menu key or select the ← or → key to adjust the angle. ●...

  • Page 101: Sing 4D

    9     U sing 4D 4D imaging enables the display of real time 3D anatomical structures. 4D imaging can only be performed by compatible volume probes. 4D imaging adds the dimension of “movement” to a 3D image by providing continuous, real-time displays of internal organs or fetus. 3D imaging provides single frame images, while 4D imaging provides continuous, high volume acquisition of 3D images.

  • Page 102: Acquiring Dynamic 3D Image

    9 Using 4D − If is highlighted, use the trackball to resize the ROI. − If is highlighted, adjust the sample line by positioning the anchor with the trackball. 7. Select the Menu key, set User Mode, Render Mode, Image Quality, Sweep Angle and Stabilization in the pop-up menu.

  • Page 103: Orking With Images

    10     W orking with Images You can work with the acquired images by using the features provided by the ultrasound system, such as the split screen display, panoramic display and annotations. 10�1 Imaging Features 10�1�1 Imaging Reverse ■  To reverse left or right Select the L/R key on the control panel to reverse the real time scan left or right. Or, select the Menu key and select LT-RT on the pop-up menu.

  • Page 104: M-Tuning

    10 Working with Images − Select the Menu key and then select Dual Live to display two real time scans if one of the two images is a Color Flow mode (C, PDI or TDI) image. The image is duplicated into two parts with two real time scans. 1 .0 cm/s 2 5 5...

  • Page 105: Harmonic Imaging

    10 Working with Images 10�1�4 Harmonic Imaging Harmonic Imaging uses the harmonic frequencies generated by tissue. The fundamental transmit frequency results in a harmonic frequency echo. The harmonic frequency received from the tissue is a multiple of the fundamental transmit frequency. The fundamental and any accompanying artifacts are missing from the harmonic frequency that the system receives.
  • Page 106 10 Working with Images ZOOM Rotate Overview Exit Figure 10-4 Real Time Panoramic Imaging You can select the Freeze key again to back to the inactivated mode. 6. Work with the image. − Zoom in/out the image a. Rotate the function key corresponding to ZOOM and the ROI is displayed on the thumbnail. b.

  • Page 107: Magnifying An Image

    10 Working with Images − Zoom in/out the image a. Rotate the function key corresponding to ZOOM and the ROI is displayed on the thumbnail. b. Use the trackball to position the interest area, and rotate the function key corresponding to ZOOM to zoom in or out this area.

  • Page 108: Cutting Cine

    10 Working with Images ■  To review the cine automatically Rotate the function key corresponding to Auto  Play in the frozen B mode to play or stop the cine review automatically. Or, rotate the function key corresponding to Cine Speed to adjust the review speed during the cine review. 10�4�2 Cutting Cine To cut the cine:...

  • Page 109: Deleting Annotations And Body Marks

    10 Working with Images 1. Select the Body Mark key on the control panel in any mode, and the cursor becomes |. 2. Position the body mark to the desired place by using the trackball, and select the Set key to add it to the image. If necessary, rotate the Angle knob to adjust the angle.

  • Page 110: Basic Procedures Of Ecg Operation

    10 Working with Images 10�6�1 Basic Procedures of ECG Operation Perform the following steps. 1. Power off the ultrasound system and connect the ECG cable to the specific port of the ultrasound system. 2. Power on the ultrasound system and attach the ECG electrodes on the patient’s body (as shown in the following figure).

  • Page 111: Reviewing Ecg

    10 Working with Images 10�6�3 Reviewing ECG Select the Freeze key on the control panel to freeze an image and the ECG waveform is frozen at the same time. Using the trackball to review the ECG waveform frame by frame. The ECG waveform is the reference for time. Basic User Manual...
  • Page 112 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 113: Anaging Images/Data

    11     M anaging Images/Data Images in this ultrasound system include frame images and cine, you can save or review them after the acquisition. Meanwhile, images can also be backed up to a USB drive or a DVD for future review if it is needed. 11�1 Storing an Image NOTE:...

  • Page 114: Viewing The Current Image/Cine

    11 Managing Images/Data 11�2�1 Viewing the Current Image/Cine ■  To view an image/cine by using the clipboard: 1. Select the T-ball key in the real time scan or frozen mode. 2. Select an image or a cine in the clipboard at the bottom of the screen by using the trackball and select the Set key to view the image/cine.

  • Page 115: Sharing Data

    11 Managing Images/Data 11�3 Sharing Data You can remotely access to the data stored in the system through a computer. Perform the following steps. 1. Connect the computer to the ultrasound system. 2. Set Image Share Service to On on the General Settings menu > Storage tab. 3.

  • Page 116: Importing Data To The System

    11 Managing Images/Data 6. Select the desired patient. 7. Click Patient Export to back up all data relevant to the patient. DVD ejects after a successful data backup export prompt is displayed. 8. Take out the DVD from the CD-ROM drive and close the tray. If only images are needed to be exported, you can export them on the View Image screen.

  • Page 117: Orking With Dicom

    12     W orking with DICOM DICOM (Digital Imaging and Communications in Medicine) is a standard created by National Electrical Manufacturers Association (ACR-NEMA) to regulate the distribution and viewing of medical images such as ultrasound images and cine. If the ultrasound system is configured with the DICOM module, you can: ●...

  • Page 118: Dicom Print

    12 Working with DICOM If you only want to send images, press the File key on the control panel to enter the View Image screen, select the desired images, and then click DICOM Send. If you want to check the status of items sent to the DICOM storage server, choose the Patient key > Patient List > DICOM Queue.

  • Page 119: Mpps

    12 Working with DICOM WorkList Search Patient Name Patient ID Accession# Date √ √ Only US Requested Procedure ID Reset 05/04/2016 05/05/2016 √ Worklist Information Patient ID Patient Name Birth Date Sex Description Requested Procedure ID Accession# Date/Time Group Case Select Cancel Figure 12-1 WorkList Screen...

  • Page 120: Storage Commitment

    12 Working with DICOM Perform the following steps. the Patient key > Patient List > Patient Review to enter the Patient Review screen. 1. Choose 2. Click PPS Screen to enter the PPS screen. PPS Screen Information Patient ID Patient Name Birth Date Sex Description State Date/Time 20140505 Mary Unknown IN PROGRESS...

  • Page 121: Dicom Queue

    12 Working with DICOM 12�7 DICOM Queue The DICOM Log is used to check the sending status of DICOM storage, DICOM print, MPPS and DICOM commitment. Choose the Patient key > Patient List > DICOM Queue to enter the DICOM Queue screen. DICOM Queue Patient ID Patient Name...
  • Page 122 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 123: Robes And Biopsy

    13     P robes and Biopsy  You should become thoroughly familiar with the operations of the probe and biopsy bracket before using them. To ensure the performance of the probe and the biopsy bracket, you should periodically check, clean, disinfect and maintain them. NOTE: A general instruction for the probe is provided in this manual.

  • Page 124: Probe Usage

    13 Probes and Biopsy 13�1�2 Probe Usage ● Use only the probes provided by the manufacturer. Otherwise, the system may not perform and an accident such as a fire may result. ● Use the probe carefully. If any part of the probe surface is scratched, immediately stop using the probe. Otherwise, electrical shock may occur.

  • Page 125: Cleaning The Probe

    13 Probes and Biopsy b. Apply an appropriate amount of coupling gel to the inside of the sheath and onto the face of the probe. c. Hold the probe and unroll the sheath onto the probe. d. Pull the probe sheath tightly over the face of the probe to remove wrinkles. e.

  • Page 126: Disinfecting Or Sterilizing The Probe

    13 Probes and Biopsy 2. Disconnect the probe from the system and remove the probe sheath and biopsy bracket from the probe. 3. Use a lint-free soft cloth dampened with mild soapy water or the recommended cleaner (see Appendix D.2 Cleaner) to wipe the probe.
  • Page 127 13 Probes and Biopsy Classification Definition Level of Disinfection Application Noncritical Devices that do not ordinarily touch Medium or low Body surface probe the patient or touch only intact skin. ■  Soaking Requirements Do not immerse the probe beyond its junction line. NOTE: Disinfectants listed in this manual are recommended because of their chemical compatibility with product materials, not their biological effectiveness.

  • Page 128: Sterilizing The Probe

    13 Probes and Biopsy Table 13-2 Recommended Method for High-level Disinfection Disinfectant Manufacturer Active Level for Active  Contact Contact Ingredient Ingredient Type Period Cidex™ Activated J&J Glutaraldehyde 2.4% Soak 45-50 minutes Dialdehyde Solution Resert XL HLD STERIS 2.0% Soak 8 minutes Chlorine Tristel Duo for Tristel 0.02% Wipe 0.5 minutes...

  • Page 129: Storage And Transportation

    13 Probes and Biopsy 2. Perform the medium-level disinfection to the probe cable as shown in Table 13-4. 3. Rinse the surfaces of the probe cable with fresh running water to completely remove the residual disinfectant. 4. Dry the probe cable with a lint-free soft dry cloth. Table 13-4 Recommended Method for Medium-level Disinfection Disinfectant Manufacturer...

  • Page 130: Available Biopsy Brackets

    13 Probes and Biopsy ● Only use the biopsy bracket in conjunction with the probe provided by the manufacturer. Otherwise, the system and probe may be damaged, an accident such as a fire may result in the worst case. ● Only trained physicians or sonographers under ultrasound guidance can handle the biopsy needle guides. During operation, the operator must observe the proper needle insertion sequencing with the needle guide in order to avoid undue discomfort and unnecessary risk and injury to the patient.

  • Page 131: Assembling The Biopsy Bracket

    13 Probes and Biopsy Biopsy Bracket Model Available Probe Model Available Biopsy Needle  Application NGB18L-A 18L-A 14G, 16G, 18G, 20G, 22G Body surface NGB9L-A 9L-A 14G, 16G, 18G, 20G, 22G Body surface NGB13L-A 13L-A 14G, 16G, 18G, 20G, 22G Body surface NGB3C-B 3C-B 14G, 16G, 18G, 20G, 22G Body surface NGB4P-B 4P-B...
  • Page 132 13 Probes and Biopsy Orientation mark 6. Attach the biopsy bracket to the probe and fasten the biopsy bracket with the locking screw. 7. Press the handle and insert the biopsy bracket tube into the biopsy bracket. 8. Insert the biopsy needle into the guide tube and make sure that the biopsy bracket is firmly attached to the probe.

  • Page 133: Preparing For A Biopsy

    13 Probes and Biopsy 10. Hold the probe attached with the biopsy bracket and unroll the sheath onto both the probe and attached biopsy bracket. ■  To assemble the endocavitary biopsy bracket Top Housing Inner Part Guide Tube Perform the following steps. 1. Check and ensure that there is no damage, deformation, malfunction, loose or missing parts on the biopsy bracket before assembly.

  • Page 134: Verifying The Biopsy Bracket

    13 Probes and Biopsy ● New, straight, biopsy needle ● Sterilized container of sterile and degassed water ● Probe attached with biopsy needle ● Activated biopsy guidelines ● Sterile probe sheath 13�2�4 Verifying the Biopsy Bracket NOTE: Ensure the biopsy bracket is properly attached to a compatible probe before verification. Perform the following steps.

  • Page 135: Cleaning The Biopsy Bracket

    13 Probes and Biopsy Biopsy Needle Biopsy Enhanced Ultrasound Image Region Line − You can select the menu item of Steer Angle, and rotate the Menu key or select the ← or → key to adjust the angle of the biopsy enhanced region line. The more closely to 90° of angle a, the stronger brightness of the biopsy needle.

  • Page 136: Storage

    13 Probes and Biopsy 4. Dry the bracket with a lint-free soft dry cloth. Table 13-5 Recommended Method for Sterilization Sterilant Manufacturer Active  Level for Active  Contact Contact Ingredient Ingredient Type Period Cidex™ Activated J&J Glutaraldehyde 2.4% Soak 10 hour Dialdehyde Solution 13�2�8 Storage Ensure the biopsy bracket is cleaned, sterilized and completely dried before storing it. Store the biopsy bracket in a sterile environment and keep it away from the environment of sudden temperature changes or direct sunlight.

  • Page 137: Ystem Maintenance

    14     S ystem Maintenance To maintain the safety and functionality of the ultrasound system, you should periodically perform the maintenance for the ultrasound system and accessories. ● To avoid electric shock and damage to the ultrasound system, power off and unplug the system from the AC power outlet before cleaning.

  • Page 138: Maintenance Checks

    14 System Maintenance ■  To clean the dust filter The dust filter must be cleaned at least every 3 months for ventilation. Power off and unplug the ultrasound system from the AC power outlet. 1. Pinch the dust filter with fingers as the figure shown above. 2.

  • Page 139: Troubleshooting

    14 System Maintenance ● Image recording using the standard probe 14�3 Troubleshooting Q1: Cannot start the ultrasound system. A1: Check whether the battery capacity is exhausted, the ultrasound system is connected to the mains supply, or the main power button is pressed down. Q2: No images are displayed on the LCD monitor.

  • Page 140: Customer Service

    14 System Maintenance For the European Economic Area (EEA), this system is subject to the Directive 2012/19/EU, as well as the correspondent national laws. This directive requires that the system and accessories must be taken to a special waste collection site at the end of their lifespans. Contact the retailer if the final disposition of the product is necessary.

  • Page 141: Appendix A Specifications

    Appendix  A  Specifications Comply with ● EN 60601-1 (IEC 60601-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance, Class I, BF, continuous operation ● EN 60601-2-37:2008 (IEC 60601-2-37:2007), Medical Electrical Equipment Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment ●...

  • Page 142: Appendix B Emc Guidance And Manufacturer's Declaration

    Appendix  B  EMC Guidance and  Manufacturer’s Declaration The EUT is classified as Group 1, Class A medical equipment according to CISPR 11. The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the EQUIPMENT should assure that it is used in such an environment. The ultrasound system is suitable for use in a professional health care environment, not including areas where there are sensitive equipment or sources of intense electromagnetic disturbances, such as the RF shielded room of an imaging system magnetic resonance imaging, operating rooms near active AF surgical equipment,...
  • Page 143 Appendix B EMC Guidance and Manufacturer’s Declaration Phenomenon Basic Standard of EMC Immunity Test Level Level of Conformity Electrostatic discharge IEC 61000-4-2 ±8 KV contact ±8 KV contact ±2 KV, ±4 KV, ±8 KV, ±2 KV, ±4 KV, ±8 ±15KV air KV, ±15KV air Radiated RF EM fields IEC 61000-4-3 3V/m 3V/m...
  • Page 144 Appendix B EMC Guidance and Manufacturer’s Declaration Test Frequency  Band  Service Modulation Maximum  Distance I m m u n i t y (MHz) (MHz) Power (W) Test  Level  (V/m) 800-960 G S M 8 0 0 / 9 0 0 , P u l s e T E T R A 8 0 0 , modulation iDEN 820, CDMA...

  • Page 145: Appendix C In Situ, Derated, And Water Value Intensities

    Appendix  C  In Situ, Derated, and  Water Value Intensities All intensity parameters are measured in water. Since water absorbs very little acoustic energy, these water measurements represent a worst case value. Biological tissue does absorb acoustic energy. The true value of the intensity at any point depends on the amount and type of tissue and the frequency of the ultra-sound that passes through the tissue.

  • Page 146: Appendix D Recommended Coupling Gel, Cleaner And Disinfectant

    Appendix  D  Recommended Coupling Gel, Cleaner and Disinfectant NOTE: • Coupling gels, cleaners and disinfectants listed in this manual are recommended because of their chemical compatibility with product materials, not their biological effectiveness. For the biological effectiveness of a disinfectant, refer to the guidelines and recommendations of the disinfectant manufacturer, Association for Practitioners in Infection Control, U.S.

  • Page 147: Cleaner

    Appendix D Recommended Coupling Gel, Cleaner and Disinfectant D�2 Cleaner Probe Model Applicable Inapplicable MPTEE Mini 7-4, MPTEE 7-4, MPTEE, MPTEE mini, Mild soapy water T - s p r a y , T - s p r a y I I , 12C-ER Transeptic, 70% IPA LAP7, C9-5, 10I2, 6CI-A, 6CT-A, 7LI4, 10I3, 10L-I,...
  • Page 148 Appendix D Recommended Coupling Gel, Cleaner and Disinfectant Probe Model Applicable Inapplicable 2P1, 5P1, 10L1, C311, C321, C343, C344, C351, C352, Cidex OPA Solution, M e t r i c i d e 2 8 , C361, C362, C511, C521, C541, C542, C543, C611, C612, Cidex, Metricide 14, Metricide 30 C721, L541, L561V, L662V, L741, L741V, L742, L743,...

  • Page 149: Appendix E Acoustic Output Data

    Appendix  E  Acoustic Output Data Please refer to Section 4.9.2 Acoustic Output.
  • Page 150 NUM. REG. ANVISA: 10069210070 www.saevo.com.br...

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