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SAEVO FT 412 Owner's Manual

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English
OWNER´S
MANUAL
FT 412
Cód.:
77000001433
- Rev.:01

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Summary of Contents for SAEVO FT 412

  • Page 1 English OWNER´S MANUAL FT 412 Cód.: 77000001433 - Rev.:01...
  • Page 2 MANUAL PRESENTATION Technical Name: Ultrasound device Trade Name: Ultrasound Diagnostic Equipment Model: FT 412 Brand: Saevo Responsável Técnico: Daniel R. de Camargo CREA-SP: 5062199650 ANVISA Registration nº: 10069210072 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 .............................. 28 4.1.4 Defined-Key Settings ............................. 29 Peripheral Device Settings ............................30 Defining Annotation Library ............................31 Body Mark Settings ..............................32 Measurement Settings ..............................33 4.5.1 General Measurement Settings ........................33 4.5.2 Application Settings ............................34 4.5.3 List Settings ..............................
  • Page 7 Contents Acquiring Spectral Doppler Images ........................... 70 6.5.1 PW Mode ............................... 70 6.5.2 CW Mode ............................... 72 6.5.3 Optimizing Spectral Doppler Images ......................74 Acquiring Triplex-Mode Images ..........................77 6.6.1 B+CFM/TDI +M ............................77 6.6.2 B+CFM/PDI/TDI +PW ..........................78 6.6.3 B+CFM/PDI+CW ............................80 7    ...
  • Page 8 Contents 10.4.1 Reviewing Cine ............................. 99 10.4.2 Cutting Cine ..............................100 10.5 Annotations and Body Marks ..........................100 10.5.1 Annotating an Image ............................ 100 10.5.2 Body Mark ..............................101 10.5.3 Deleting Annotations and Body Marks ......................101 10.6 Using ECG ................................101 10.6.1 Basic Procedures of ECG Operation ......................
  • Page 9 Contents 14     S ystem Maintenance �������������������������������������������������������������������������������������������������������������������������������������� 129 14.1 Cleaning the System..............................129 14.2 Maintenance Checks ..............................130 14.3 Troubleshooting ............................... 130 14.4 Replacing the Fuse ..............................131 14.5 Equipment Disposal ..............................131 14.6 Precautions for the Reduction of the Environment Impact ..................131 14.7 Precautions in Case of Destruction of the System ....................
  • 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 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 ● Do not knock or shake the system. ● Ensure that the casters are intact and can rotate well before moving the system. ● Always use the handle to move the system. ● Ensure that the foot brakes are released and all cables are away from the casters before moving the system. 1�2�3 Accessories Caring ●...

  • Page 14: Biological Safety

    1 Safety ● You should be familiar with the performances and operations of the system, observe the ultrasound output parameters on the screen at all times. 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.

  • Page 15: Transducer Surface Temperature Limits

    1 Safety − Cranial Bone Thermal Index (TIC) is used when bone is near the skin surface as in transcranial examination, it provides an estimate of potential temperature rise in the bone or adjacent soft tissue. ■  MI/TI Display TI and MI values are displayed in real time 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 Foot switch connector Protective earth (ground) Equipotentiality Alternating current Degree of IP protection Non-ionizing electromagnetic radiation Manufacturer Date of manufacture Follow instructions for use Network port USB port Fragile Keep dry No stacking Maximum stacking limit of packages Maximum of two layers allowed for the monitor Keep this way upward Serial number...
  • Page 17 1 Safety Symbol Meaning 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: System Overview

    2       System 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 following items:...

  • Page 20: Peripheral Device Panel

    2 System Overview LCD Monitor 12 Pencil Probe Port Control Panel 13 Probe Holder Coupling Gel Holder 14 Cable Hanger Front Handle 15 Speaker Transducer Cable Hanger 16 Fan Probe Port 17 Cable Hanger Power Indicator 18 Dust Filter Charging/Discharging Indicator 19 Peripheral Device Panel Battery Capacity Indicator 20 DVD Drive (optional)

  • Page 21: Control Panel

    2 System Overview No� Name Description Video Output Used for connecting a video device to acquire compound signals, such as video printer. 2�3�2 Control Panel <2> <1> <19> <15> <16> <17> <18> <4> <5> <3> <36> <8> <6> <7> <25> <20> <21>...
  • Page 22 2 System Overview No� Name Description <8> Dual Press it to enter the dual split display. Or, press it to activate the desired image in the dual split display. <9> ANGLE ● Rotate it to adjust the flow direction in the PW/CW mode. ●...

  • Page 23: Key Panel

    2 System Overview No� Name Description <31> Caliper Press to activate the basic measurement and calculation features. ● Press it to perform the distance measurement in the 2D (B/CFM/PDI/TDI)/ M/3D/4D mode. ● Or, press it to activate a velocity measurement in the PW/CW mode. <32>...
  • Page 24 2 System Overview No� Name Description Contrast Press it to enter the contrast imaging mode. Elasto Press it to enter the eastography imaging mode. 10> Biopsy Press it to activate the biopsy feature. 11> Press it to enter the TDI mode. 3D/4D Press it to enter or exit the 3D/4D mode.

  • Page 25: Basic Screen

    2 System Overview 2�3�4 Basic Screen Mar-23-2012 16:08:16 MI 0.2 TIS 0.7 New hosp. XXX /C-Vascular Operator 20121212234565 Patient cm/s 17 16 Figure 2-5 Basic Screen 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...
  • Page 26 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 27: Reparing The System

    3     P reparing the System System preparation is necessary before using the system. The preparation includes but is not limit to moving, positioning or adjusting the system, connecting the probe and the peripheral devices. 3�1 System Assembly Only service personnel authorized by the manufacturer can assemble the system. Ensure the system is firmly assembled before it is powered on.

  • Page 28: System Moving/Positioning

    3 Preparing the System 3�2 System Moving/Positioning Leave at least 20cm at the back and both sides of the system for ventilation. Otherwise, the temperature rise could cause failures. Unlock Lock Brake Perform the following steps to position the system. 1. Unlock the four foot brakes. 2.

  • Page 29: Using The Battery

    3 Preparing the System 3�3�2 Using the Battery ● Do not disassemble or alter the battery. Otherwise, there is a danger of explosion. ● Replace the battery with the same or the equivalent type. ● Do not short-circuit the battery by directly connecting the system with metal objects. ●...

  • Page 30: Powering On/Off The System

    3 Preparing the System Table 3-1 Indicator Descriptions Status Indicator Mains Supply Battery Supply Yellow, charging Battery Charging Indicator Green, fully charged Green Mains Supply Indicator Green, full capacity Battery Discharging Indicator Yellow, low capacity Blinking yellow, extremely low capacity, the system automatically shuts down and a buzzer beeps.

  • Page 31: Adjusting The System

    3 Preparing the System 3�5 Adjusting the System 3�5�1 Adjusting the Monitor Arm NOTE: • Be careful with your fingers when adjusting the monitor arm. • Lock all four casters before you adjust the monitor arm. 10cm 30° 30° ● To adjust the monitor vertically, move the upper arm forwards or backwards from the lower arm. ●...

  • Page 32: Connecting The Probe

    3 Preparing the System 180° ■  To adjust the brightness and contrast Adjusting the LCD monitor’s brightness and contrast is one of the most important factors for obtaining the optimum image. The proper setup displays a complete gray scale. The lowest level of black should just disappear into the background and the highest white should be bright, but not saturated.

  • Page 33: Connecting The Peripheral Device

    3 Preparing the System ■  Disconnecting the probe Rotate the locking lever 90°anticlockwise to the horizontal position, and then pull the probe connector straight out vertically. 3�7 Connecting the Peripheral Device 3�7�1 Connecting the Foot Switch ● To avoid damaging the foot switch, do not place the foot switch on the system. ●...

  • Page 34: 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 35: Ustomizing Your System

    4     C ustomizing Your System The System Setting menu allows you to specify general system settings, printing, measurement and calculation settings. You can also define the annotation library and shortcut keys. All your customized settings can remain even after rebooting the system. After starting up the system, the LCD monitor displays the application mode screen as shown in Figure 6-1.
  • Page 36 4 Customizing Your System Item Description Hospital Name Enter the institution’s name. Freeze Response Select the feature to be enabled after you select the Freeze key. Trackball Sensitivity Adjust the sensitivity for the trackball movement. A greater value brings about a higher sensitivity.

  • Page 37: Display Settings

    4 Customizing Your System 4�1�2 Display Settings System Setting General Display Storage KeyConfig General Peripheral Color of ROI Cyan Comment Display Format V1/2 Bodymark Screen Saver Measure Screen Saver Delay(min) 30 Report Annot Font Size Medium DICOM Load Default About Show Gallery Save&Exit Show Images In Gallery...

  • Page 38: Storage Settings

    4 Customizing Your System Show Gallery Gallery Config Down Bottom Import Delete Load Default Exit Figure 4-3 Show Gallery Screen 2. Load default demos or import demos stored in an external storage device. − Select a demo and click Top, Up, Down or Bottom to arrange the order. −...

  • Page 39: Defined-Key Settings

    4 Customizing Your System Item Description Clip Format Set the cine storage format. Still Format Set the image storage format. Store Frame Amount Set the maximum number of frames for cine. Print&Store Region Set the area to be printed out. Image Share Service Enable or disable the share feature.

  • Page 40: Peripheral Device Settings

    4 Customizing Your System Item Description Tick it and press the Save, P1 or P2 key to send the desired image to the DICOM storage DICOM Print server. You can select the specific DICOM print server from the drop-down list when defining the P1 or P2 key.

  • Page 41: Defining Annotation Library

    4 Customizing Your System Item Description Mac Address View the MAC address of the system. Ping IP Addr. Type an IP address and click Ping to test the connection. ■  Wireless Settings Item Description Wireless Network Enable or disable access to a wireless network. Name Displays the name of the wireless network.

  • Page 42: Body Mark Settings

    4 Customizing Your System System Setting General BREAST CARD Peripheral Selected Comment Bodymark L-Lobe Measure Hepatic A Pancreas Report R-Lobe DICOM Head.Panc Load Default Edit Comment Item Spleen About Liver Caudate M.Hepat.V Add To Lib Duct.Panc Body.Panc Delete Splenic V Save&Exit Exit Figure 4-7 Annotation Settings Menu...

  • Page 43: Measurement Settings

    4 Customizing Your System 2. Select a body mark library from the drop-down list beside Application of Available. 3. Add desired body marks in the selected body mark library to the Selected list. − Select a body mark and then click > to add it to the Selected list. −...

  • Page 44: Application Settings

    4 Customizing Your System Item Description Line ID Disp. Enable or disable the display of line number when performing a measurement. Keep Result Window Enable or disable the display of the current result box when unfreezing the image. Result Font Size Set the font size of the result box.
  • Page 45 4 Customizing Your System ■  Obstetrics Measurement Settings Set the formula for obstetrics measurement. 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.
  • Page 46 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 4-11 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 4-12 Growth Table 3.

  • Page 47: List Settings

    4 Customizing Your System 4�5�3 List Settings System Setting List Application 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 48: 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 49: Configuring Dicom

    4 Customizing Your System 4�7 Configuring DICOM 4�7�1 Storage Service Settings You can connect the system to the DICOM storage server and adjust the relevant settings through the Storage Service tab. System Setting Store C-Store Worklist MPPS Print General Peripheral Service List Delete DicomStore Comment DICOM Image Storage...

  • Page 50: Commitment Settings

    4 Customizing Your System Item Description Send After Every Image Tick this item and the system sends an image to the DICOM storage server every Stored time the image is saved. Send At End of Exam Tick this item and the system sends all saved images to the DICOM storage server after the exam is complete.

  • Page 51: Dicom Worklist Settings

    4 Customizing Your System Item Description 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. Dimse Timeout(sec) Set the timeout time for sending the Dimse command. Acse Timeout(sec) Set the timeout time for sending the Acse command Synchronously Receive...

  • Page 52: Mpps Settings

    4 Customizing Your System Item Description IP Address Set the IP address of the DICOM worklist server. After the setting, 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 53: Print Service Settings

    4 Customizing Your System Item Description Remote Host Name Enter the name of the MPPS server. IP Address Set the IP address of the MPPS server. After the setting, click Ping to test the connection. DICOM AE Title Set the Application Entity (AE) title of the MPPS server. Port Number Set the port number of the MPPS server.

  • Page 54: Defining System Defaults

    4 Customizing Your System Item Description Service List Select the DICOM print server. ● Select Append from the drop-down list beside Service List, input the relevant 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 Host Name Enter the name of the DICOM print server.

  • Page 55: Loading System Defaults

    4 Customizing Your System System Setting General Load Export/Import Peripheral Comment Bodymark default Measure Report DICOM Load Default About Save&Exit Exit Figure 4-20 Loading Defaults Menu 4�8�1 Loading System Defaults 1. Click Load, select a setting name, and then a dialogue box appears. 2.

  • Page 56: Viewing System Information

    4 Customizing Your System System Setting General Load Export/Import Peripheral Comment Make sure USB drive in the USB slot Bodymark Measure Report Copy user setting to USB DICOM Copy user preset to USB Load Default Load USB user setting to system About Load USB user preset to system Export Log...
  • Page 57 4 Customizing Your System System Setting General General Acoustic Output Peripheral Register Type Comment Bodymark Probe Type Measure Report Exam Type DICOM Load Default About Save&Exit Exit Figure 4-21 About Menu - Acoustic Output Tab Basic User Manual...
  • Page 58 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 59: 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 instructions: ●...
  • Page 60 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 Name Enter First Name, M�I (middle name) or Last Name of the patient.

  • Page 61: Retrieving Archived Information

    5 Preparing for an Exam Refering.M.D/Performing.M.D/ Enter manually the name. Sonographer Comment Enter manually the notice or necessary information. 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.

  • Page 62: 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 63: 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. Press 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 64 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 65: 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 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 press the Probe key to enter the application mode screen from other screens.
  • Page 66 6 Acquiring Images Going to User Pre-Set Menu Are you sure(Y/N) ？ 4. Press the Y key to enter the User preset screen. Create preset Probe Presets display Exam Name Exam Type < > Vascular Exam Icon < > C-Vascular Create Exam Replace Exam Exit Figure 6-2 User Preset Menu...

  • Page 67: Acquiring B-Mode Images

    6 Acquiring Images Create preset Preset Exam Cardiology(s) Presets display Liver(s) Granial(s) Difficult(s) new(u) Delete Exit Restore Factory Default Figure 6-3 Preset Display Menu ● Click one desired application preset, click to arrange the preset on the application mode screen. ● Click one desired application, click Delete > Yes to delete the application preset. ●...
  • Page 68 6 Acquiring Images NOTE: You can adjust all parameters in the real time B mode, but can only adjust Chroma and GSC in the frozen B mode. ■  Gain The B mode gain (2D gain) determines the amplifying factors for the received echoes and the brightness of the ultrasound image.
  • Page 69 6 Acquiring Images ● Flip the DEPTH switch upwards to decrease the depth range of the 2D image and the ultrasound image is magnified. ● Flip the DEPTH switch downwards to increase the depth range of the 2D image and the size of image is reduced to display the entire ultrasound image.
  • Page 70 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 71 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 1%-100%, and ±1% can be adjusted each time. The real time value of the power is displayed in the imaging information area on the basic screen.

  • Page 72: Acquiring Color Flow Images

    6 Acquiring Images To use trapezoidal imaging: 1. Press the MENU key in the real-time mode to display a menu. 2. Use the trackball or press the up/down arrow key to select Trapezoid on the pop-up menu. 3. Rotate the MENU knob or press the left/right arrow key to enable or disable the feature. NOTE: Only the linear probes are available for trapezoidal imaging.

  • Page 73: Pdi Mode

    6 Acquiring Images 6�3�2 PDI Mode PDI (Power Dopper Imaging) is a color flow imaging technology which adds the flow signal in the CFM-mode image. PDI uses the number and amplitude of red blood cells going through in the flow to create the color- coded imaging.

  • Page 74: Optimizing Cfm/Pdi/Tdi Mode Images

    6 Acquiring Images cm/s 2 5 5 1 / 5 0 2D Imaging Color Flow ROI 2 . 2 Figure 6-7 TDI-Mode Imaging Screen 3. Adjust color flow ROI. − Use the trackball to position color flow ROI. − Press the confirm key on the control panel to adjust the size of color flow ROI. −...
  • Page 75 6 Acquiring Images 3. Rotate the MENU knob or press the left/right arrow key to adjust the value. ■  Pulse Repetition Frequency Pulse repetition frequency is used to adjust the velocity scale. To adjust the pulse repetition frequency: ● Flip the PRF switch upwards to increase the value. ●...
  • Page 76 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 77: Acquiring M-Mode Images

    6 Acquiring Images NOTE: Only the linear probes are available when adjusting steer. ■  Flow Invert Flow invert is used to view blood flow from a different perspective. When Flow Invert is set to OFF, red pixels represent flow to the probe; blue pixels represent flow away from the probe.

  • Page 78: Anatomical M-Mode

    6 Acquiring Images Y-axis: depth 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 79: Optimizing M-Mode Images

    6 Acquiring Images − Press the confirm key on the control panel to select the desired M-line. − Position the desired M-line by using the trackball. − Rotate the ANGLE knob on the control panel to adjust the angle of M line. 3.

  • Page 80: Acquiring Spectral Doppler Images

    6 Acquiring Images ■  Display Format Display format is used to view the image better. To set the display format: 1. Press the MENU key in the M mode to display a menu. 2. Use the trackball or the up/down arrow key to select Dis Format on the pop-up menu. 3.
  • Page 81 6 Acquiring Images Secptral Doppler Line Flow Cursor Sample Volum 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 82: Cw Mode

    6 Acquiring Images 6. Optimize the PW-mode image. For details, refer to Section 6.5.3 Optimizing Spectral Doppler Mode Images. If needed, press the Update key on the control panel to enter the inactivated B+PW mode 2, the following screen appears. cm/s Y-axis: Frequency...
  • Page 83 6 Acquiring Images − Adjust the angle of the spectral Doppler line by moving the trackball to the left or the right. − Press the confirm key on the control panel to confirm. 4. Rotate the ANGLE knob on the control panel to adjust the angle of the flow cursor. 5.

  • Page 84: 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. Press the CW key again to exit. 6�5�3 Optimizing Spectral Doppler Images After activating the Doppler trace, press the MENU key on the control panel, the screen displays all controls related to the PW/CW-mode imaging, you can use them to optimize PW/CW-mode images.
  • Page 85 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 86 6 Acquiring Images 3. Rotate the MENU knob or press the left/right arrow key to adjust the value. ■  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 87: Acquiring Triplex-Mode Images

    6 Acquiring Images ■  Video Invert Video invert is used to view the background of the spectral display from a different perspective. To enable or disable the flow invert: 1. Press the MENU key in the M mode to display a menu. 2.

  • Page 88: B+Cfm/Pdi/Tdi +Pw

    6 Acquiring Images M-line Color Flow ROI 2D Imaging Figure 6-17 Inactivated B+CFM/TDI +M-Mode Imaging Screen 3. Adjust the M line by using the trackball. 4. Press the Update key on the control panel to activate the M mode. The basic screen displays the following after being activated. Y-axis: depth X-axis: time Figure 6-18 B+CFM/TDI +M-Mode Imaging Screen...
  • Page 89 6 Acquiring Images Spectral Doppler Line Flow Cursor Sample Volume Gate 2D Imaging cm/s Color ROI Figure 6-19 Inactivated B+CFM/PDI/TDI+PW-Mode 1 Imaging Screen 3. Adjust the position and angle of the spectral Doppler line. − Position the sample volume gate on the spectral Doppler line by moving the trackball upwards or downwards.

  • Page 90: B+Cfm/Pdi+Cw

    6 Acquiring Images cm/s Y-axis: Frequency X-axis: Time Figure 6-21 Inactivated CFM/PDI/TDI+PW Mode 2 Imaging Screen You can also adjust the position and angle of spectral Doppler line, the size of the sample volume gate, and the direction of the flow cursor. 7. Press the PW key again to exit. 6�6�3 B+CFM/PDI+CW For details, refer to Section 6.6.2 B+CFM/PDI/TDI +PW.

  • Page 91: 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. Furthermore, it provides an elastography image to discover tumors (stiffer than the surrounding tissue). 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 92: Optimizing Elastography Images

    7 Elastography Imaging − Ensure the compression is applied perpendicularly, and all parts of the target lesion are compressed uniformly. − Ensure the compression is a dynamic intermittent force, i.e. alternate tension with relaxation, which could keep the distorted tissue back to normal status. If the distorted tissue is not relaxed, the tissue cannot be distorted and the elastography imaging cannot be performed.

  • Page 93: 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. Press the MENU key to display a menu. 2. Use the trackball or press the up/down arrow key to select Transparency on the pop-up menu. 3.
  • Page 94 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 95: 3 D Imaging

    8     3 D Imaging 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 exams, and can be used to see the three dimensional volume image of the internal organs or a fetus.

  • Page 96: Working With 3D Images

    8 3D Imaging − If is highlighted, use the trackball to position the ROI. − 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.

  • Page 97: Setting Display Format

    8 3D Imaging 2. Move the cursor on the image of View A, B or C by using the trackball, and press the confirm key to select the desired reference image. 3. Adjust images inside the ROI on the reference image. Anchor View B View A...

  • Page 98: Cropping Reviews With Trace

    8 3D Imaging 1. Select the MENU key and a menu pops up on the screen. 2. Select Render Mode by using ↑ or ↓ key. 3. Rotate the MENU key or select <- or > key to make the setting. NOTE: The imaging render mode can be also set in the inactivated 3D mode.

  • Page 99: Optimizing 3D Image

    8 3D Imaging 2. Move the cursor on an image and press the confirm key to select the desired reference image. ■  To move images  Press the up/down/left/right arrow key to move images. ■  To rotate images ● Move the cursor on an image, press the confirm key, and then rotate the image by using the trackball. ●...

  • Page 100: Setting The Scan Mode

    8 3D Imaging 2. Select the menu item of Slice Number and rotate the MENU knob or press the left/right arrow key to set the slice number to 9, 16 or 25. In the following figure, the slice on the X axis (Ref A, number: 9) is taken as an example. Central Slice Slice Slice Area...

  • Page 101: Restoring The Image

    8 3D Imaging ● If Scan Method is set to Sector, you can adjust the sweep angle when performing the scan by the probe. Press the up/down arrow key to select ZAngle on the pop-up menu, and then rotate the MENU knob or press the left/ right arrow key to adjust the angle.
  • Page 102 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 103: 4 D Imaging

    9     4 D Imaging 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 104: Acquiring Dynamic 3D Image

    9 4D Imaging − If is highlighted, use the trackball to position the ROI. − 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.

  • Page 105: Orking With Images

    10     W orking with Images You can work with the acquired images by using the features provided by the system, such as the split screen display, panoramic display and annotations. 10�1 Imaging Features 10�1�1 Imaging Reverse Press on the key panel to reverse the real time scan left or right. Press on the key panel to reverse the real time scan up or down.

  • Page 106: M-Tuning

    10 Working with Images 1 .0 cm/s 1/50 Figure 10-2 Real Time CFM + Real Time B ■  Quad-Split Screen Display 1. Press the B, CFM, PDI or TDI key on the control panel to enter a real time scan. 2. Press on the control panel to enter the quad split screen display. The B-mode image is taken as an example in the following figure.

  • Page 107: Panoramic Imaging

    10 Working with Images harmonic frequency that the system receives. The artifact reduction, and the concomitant reduction in haze and clutter, increases contrast resolution and improves border delineation. THI is useful in difficult-to-image patients. In real time scan of B mode, press the THI key on the key panel to enter the THI mode, and THI or PHI appears at the lower left corner of the screen.
  • Page 108 10 Working with Images Figure 10-4 Real-Time Panoramic Imaging Screen 6. Work with the image. − Magnify the Image Press the MENU key on the control panel to display a menu. Select ZOOM on the pop-up menu, and a ROI appears on the thumbnail. Rotate the MENU knob or press the left/right arrow to adjust the size of ROI.

  • Page 109: Magnifying An Image

    10 Working with Images 3. Work with the image. − Magnify the Image Press the MENU key on the control panel to display a menu. Select ZOOM on the pop-up menu, and a ROI appears on the thumbnail. Rotate the MENU knob or press the left/right arrow to adjust the size of ROI. Press the MENU key to exit the menu, and then use the trackball to position the ROI.

  • Page 110: Cutting Cine

    10 Working with Images NOTE: • You can adjust the parameter settings when review cine. You can select Start or End on the pop-up menu, and press the left/right arrow key to review the first or last • frame. ■  To review cine automatically You can press the MENU key, use the trackball or press the up/down key to select Play/Stop on the pop-up menu, and then rotate the MENU knob or press the left/right arrow key to play or stop the cine review automatically.

  • Page 111: Body Mark

    10 Working with Images Repeat the above steps to add more arrows if needed. 10�5�2 Body Mark Perform the following steps. 1. Press the Body Mark key on the control panel. The first body mark of the exam type is added to the image by default. 2.

  • Page 112: Basic Procedures Of Ecg Operation

    10 Working with Images ● This ECG module is not suitable for intracardiac use or direct cardiac contact. ● This ECG module provides 3-channel ECG signals and cannot be used for diagnosis and monitoring. ● To avoid electrical shock, ensure the ECG cable is intact and correctly connected. ●...

  • Page 113: Reviewing Ecg

    10 Working with Images Item Description R-Trigger Enable or disable the R-trigger function. When enabled, the R-Trigger menu pops up, the menu contains Trigger Delay, Frame Count, and Frame Int. NOTE: In order to enable the R-trigger function, you should disable the compounding imaging function first.
  • Page 114 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 115: 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 be also backed up to a USB device or a DVD for future review if it is needed. 11�1 Storing an Image NOTE:...

  • Page 116: Retrieving An Image

    11 Managing Images/Data − To view an image on the View Image screen 3. Press the Review key on the control panel to enter the View Image screen. The following screen is displayed with images and cine thumbnails. View Image Patient ID：345 Patient Name: Mary Exam Files Number: 19 All Select...

  • Page 117: Backing Up Data

    11 Managing Images/Data 11�4 Backing up Data ● All data is saved to the system by default. To avoid data loss due to unexpected system breakdown or software update, you are highly recommended to back up data backup. ● Complete all exams before backing up the data. 11�4�1 Backing up Data to the USB drive Perform the following steps.
  • Page 118 11 Managing Images/Data 3. Select the imported device from the Import/Export drop-down list. 4. Click Export Screen and then select the imported patient information. 5. Click Patient Import to import the desired data. Basic User Manual...

  • Page 119: 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 system is configured with the DICOM module, you can: Search the archived patient information set on the DICOM server, and copy the patient information to the system so that ●...

  • Page 120: Dicom Print

    12 Working with DICOM If you only want to send images, press the Review 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 121: 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 122: Storage Commitment

    12 Working with DICOM 1. Choose the Patient key > Patient List > Patient Review to enter the Patient Review screen. 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 Scheduled Procedure Step Information Code Description Meaning Append...

  • Page 123: 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. Choose the Patient key > Patient List > DICOM Queue to enter the DICOM Queue screen. DICOM Queue Patient ID Patient Name Search Date...
  • Page 124 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 125: Robes And Biopsy

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

  • Page 126: 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 127: 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 128: Disinfecting And Sterilizing The Probe

    13 Probes and Biopsy 13�1�4 Disinfecting and Sterilizing the Probe ● There is a cleared list of sterilants and high-level disinfectants for use in processing reusable medical and dental devices on the FDA website. That list can be consulted to find agents that may be useful for probe disinfection. Please refer to the following URL for FDA-Cleared Sterilants and High Level Disinfectants: http://www.fda.
  • Page 129 13 Probes and Biopsy Perform the following steps. 1. Clean the probe. For details, refer to Section 13.1.3 Cleaning the Probe. 2. Perform the medium-level disinfection to the probe as shown in Table 13-1. Or select a recommended disinfectant (see Appendix D.3) to disinfect the probe by following the instruction provided by disinfectant’s manufacturer.

  • Page 130: Disinfecting And Sterilizing The Probe Cable

    13 Probes and Biopsy ■  To sterilize the probe You should sterilize the intraoperative, biopsy use probe or any probe that comes into contact with blood after each use. Perform the following steps: 1. Clean the probe. For details, refer to Section 13.1.3 Cleaning the Probe. 2.

  • Page 131: Storage And Transportation

    13 Probes and Biopsy ■  Sterilization If the probe cable comes into contact with any blood or body fluids, you should sterilize it. For details, refer to the information about probe sterilization. 13�1�6 Storage and Transportation You should store or transport the probe in accordance with Appendix A Specifications. ■ ...

  • Page 132: Available Biopsy Brackets

    13 Probes and Biopsy 13�2�1 Available Biopsy Brackets Biopsy Available Available Biopsy Needle  Application Bracket Model  Probe Model NGBC322 C322 14G, 16G, 18G, 20G, 22G Body surface NGBC344 C344 14G, 16G, 18G, 20G, 22G Body surface NGBC354 C354 14G, 16G, 18G, 20G, 22G Body surface NGBC611 C611 14G, 16G, 18G, 20G, 22G Body surface...
  • Page 133 13 Probes and Biopsy 1. Check and ensure that there is no damage, deformation, malfunction, loose or missing parts on the biopsy bracket before assembly. 2. Wear sterile gloves. 3. Unfold the probe sheath and apply an appropriate amount of coupling gel to the inside of the sheath and onto the face of the probe.
  • Page 134 13 Probes and Biopsy 9. Unfold another probe sheath, and apply an appropriate amount of coupling gel to the inside of the sheath. 10. Hold the probe attached with the biopsy bracket and unroll the sheath onto both the probe and attached biopsy bracket.

  • Page 135: Preparing For A Biopsy

    13 Probes and Biopsy 8. Insert the biopsy needle into the guide tube. 9. Check if the bracket has been firmly attached to the probe. If it is loose, reattach the biopsy bracket. 10. Unfold another probe sheath, and apply an appropriate amount of coupling gel into the sheath. 11.

  • Page 136: Cleaning The Biopsy Bracket

    13 Probes and Biopsy 5. Perform a scan to locate the target. 6. Perform the puncture by sliding the needle through the groove in the guide until the needle, as shown on the display, intercepts the target. If you want to adjust the biopsy guidelines, you can press the MENU key, select Biopsy Cali� on the pop-up menu, and then rotate the MENU knob or press the left/right arrow key to display the biopsy calibration menu.

  • Page 137: Sterilizing The Biopsy Bracket

    13 Probes and Biopsy 13�2�7 Sterilizing the Biopsy Bracket ● Disinfect the biopsy bracket after each use. ● Use the liquid sterilant that meets with the local laws and regulations. ● If you use the recommended sterilant, ensure the requirements for the sterilant level and probe soak period are met.
  • Page 138 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 139: Ystem Maintenance

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

  • Page 140: Maintenance Checks

    14 System Maintenance 3. Turn the ring anticlockwise until the ring lifts. 4. Take out the ring and ball (be careful not to drop the ball) from the control panel. 5. Use a lint-free soft cloth dampened with 75% ethanol to clean the trackball. 6.

  • Page 141: Replacing The Fuse

    14 System Maintenance Q3: The LCD monitor displays abnormal. A3: Check whether you selected the appropriate probe and a compatible exam type, or optimized imaging parameters correctly. For details, refer to Chapter 6 Acquiring Images. Q4: The measurement cannot be performed after pressing the Cal key on the control panel. A4: Ensure you pressing the Cal key in the frozen mode.

  • Page 142: Precautions In Case Of Destruction Of The System

    14 System Maintenance 14�7 Precautions in Case of Destruction of the System The system must not be disposed of as domestic waste. To avoid environmental contamination or inappropriate use of the ultrasound system when it is destroyed, they must be disposed of (according to the current legislation) in an appropriate place. Otherwise, it may contaminate the environment.

  • Page 143: 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 144: 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 145 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 146 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 147: 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 148: 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 149: 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, 12C- Mild soapy water T-spray, T-spray II, Transeptic, 70% IPA LAP7, C9-5, 10I2, 6CI-A, 6CT-A, 7LI4, 10I3, 10L-I, 12L-I, T-spray, T-spray II, Transeptic, 70% IPA 12LI-A, 12LT-A...

  • Page 150: Appendix E Acoustic Output Data

    Appendix  E  Acoustic Output Data Please refer to Section 4.9.2 Acoustic Output.
  • Page 151 NUM. REG. ANVISA: 10069210072 www.saevo.com.br...

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