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1. 2 2 0 45 53 DLA Saving Mages a quais se See OSS BIER RL RS E eee 54 5 2 Cine Review esses ss ee wee GE eee Re ee OY 54 5 3 M Mode Cine Review 00 eee ee ee ee eee 55 5 4 Clipboard sag ee eee a a AE TAVA RA hee 55 5 5 Note for Biplane Transducers a 55 6 Transducers 57 6 1 Transducer Information o 57 6 1 1 Supported Transducers and Intended Applications 57 6 2 Environmental Requirements 0000 eee eee 57 6 3 Preparation and Usage of the Probe o o 58 6 3 1 SPECION ii dio eos eia o da acts Se ee A 58 6 3 2 Probe Connection e 58 6 3 3 Preparation for Scanning e 58 For Surface Probes sis ti RA 58 For intracavitary probes o oo ee eee eee 58 63 4 SCA sos see o sm E A E 59 6 4 Probe Maintenance Cleaning and Disinfection 59 SonoScape 2 AGV A5V User Manual Contents 6 4 1 Probe immersion level 59 6 4 2 Cleaning Instructions a oaoa a ee eee ee 60 6 4 3 Disinfection Instructions aoaaa a ee ee ee eee 60 7 System Maintenance 61 7 1 Guidance for Service e ee 61 7 2 Manufacturer Responsibility oaoa o 61 7 3 Contact Information 62 A Information of EU Representative 63 SonoScape A6V A5V User Manual 3 1 1 System Safety
2. to go to the parent directory Operations applied to files Copy and Paste Select a file click Copy Go to the target directory and click Paste to paste the file into the directory Delete Select a file click this button to delete it Rename Click it to rename the selected file Two file files must not have the same name Other operations Dicom Trans If the DICOM package is installed click this button to transfer the selected file s through DICOM FTP access You can also access the data stored on the ultrasound system us ing a PC through FTP Read instructions in Figure 3 13 to make connection and configurations Load File Click this button to view the selected file Delete Select a file click this button to delete it Burn Click this button to activate the file burning window see Figure 3 14 Instructions are introduced in subsection 3 9 1 Connection Connect the ultrasound system and the PC to the same network through a router Ethernet Cable SonoScape Ultrasound System c F PC Configuring IP on the ultrasound system Refer to Figure 3 5 to set up the IP address i e set the static IP address to 10 0 0 XXX netmask to 255 255 255 0 and gateway to 10 0 0 1 Configuring IP on the PC Set the static IP address to 10 0 0 YYY netmask to 255 255 255 0 and gateway to 10 0 0 1 The only configuration difference between the PC and the ultrasound system is at their static IP addres
3. Description To measure the length of the body and calculate the GA Instructions 1 Press Calc highlight OB Feline for feline or Canine for canine and press SET 2 Highlight FL in the submenu and press SET 3 Draw a line segment to measure the FL 4 The BD and the GA will be displayed Trunk measurement Description To measure the trunk length and calculate the GA Instructions 1 Press Calc highlight OB_Ovine for ovine or OB_Bovine for bovine and press SET 2 Highlight OFD in the submenu and press SET 3 Draw a line segment to measure the OFD 4 The trunk length and the GA will be displayed 4 2 2 Gynecology Measurements GYN Uterus UT Description To measure the length UT L width UT W and height UT H of uterus and calculate UT UT UT L UT W UT H in units of centimeters Instructions 1 Press Calc highlight GYN and press SET 2 Highlight UT in the submenu and press SET 3 Draw a line segment to measure UT L 4 Continue to measure UT W and UT H in the same manner SonoScape 40 A6V A5V User Manual 4 2 BMode Advanced Measurements 5 The measurement results and UT will be displayed Endometrium Thickness Endo Description To measure the thickness of endometrium Instructions 1 Press Calc highlight GYN and press SET 2 Highlight Endo in the submenu and press SET 3 Draw a line segment representing the endometrium thickness 4 The measurem
4. Safety Overview This chapter discusses the measures concerning the safety of the patient and the operator To ensure the safety of the operator and the patient please read this chapter carefully before operating this system Warning information also provided in this manual should be followed carefully Any violation of the relevant rules may result in personal injury or even endanger human life The following precautions should be adhered to e This system shall be operated only by or under the guidance of a qualified person e This system complies with Type B general equipment Class I of EN606601 1 1990 A1 1993 A2 1995 standard There are no user adjustable parts inside the system Under no circumstances should this equipment be modified Any modifications must be made by the technicians authorized by the manufacturer In case of system malfunction turn off the power supply immediately and inform our representative nearest to you The power cable of the system must be connected to a power socket which has an effective earth pin Connect this system either electronically or mechanically only with the devices com plying with the EN606601 1 1990 A1 1993 A2 1995 standard Recheck the leak age current and other safety performance indices of the entire system to avoid poten tial system damage caused by leakage from a current superposition The equipment has no specialized design to enable it working with high frequency device
5. Relative humidity 30 75 no condensation Temperature 10 40 C Barometric Pressure 700 1060 hPa Strong electromagnetic EM waves may interfere with the system and cause ghosting or noise on the screen The system should be shielded from any strong EM waves and kept away from any strong radiation sources Keep the objects or devices used for the ultrasound scan tidy and clean Do not leave any objects e g manuals transducers on the keyboard When the system is not in use be sure to turn off the power supply Protect the system from dust by covering it with a dust cover Environmental Requirements for Transport and Storage Relative humidity 20 90 no condensation Temperature 20 55 C Barometric Pressure 700 1060 hPa Electrical Requirements Power Requirements 100 240V 50 60Hz Power Consumption 130 VA Supply voltage The maximum fluctuation should be within 10 otherwise the system can be damaged Grounding Before connection to the power supply connect the system to the pro tective earth using the ground wire supplied with the system Note To avoid damaging the system ensure to use the power supply which meets the above requirements Mains voltages and frequencies in different countries or regions may vary Power requirements are also indicated on the rear panel next to the mains power input socket Electrical Safety Classification This system complies with Type B Class I EN60
6. for canine and press SET 2 Highlight GS in the submenu and press SET 3 Draw a line segment representing the GS diameter 4 The GS diameter and the GA will be displayed The GA is calculated using the formula table defined in the system Crown Rump Length CRL measurement Description To measure the crown rump length CRL and calculate the Gestational Age GA Instructions 1 Press Calc highlight OB Ovine for ovine OB Canine for canine or OB Bovine for bovine and press SET 2 Highlight CRL in the submenu and press SET 3 Draw a line segment to measure the CRL SonoScape A6V ASV User Manual 39 4 MEASUREMENTS 4 The CRL and the GA will be displayed Biparietal Diameter BPD measurement Description To measure the biparietal diameter BPD the transverse diameter of the head and calculate the Gestational Age GA Instructions 1 Press Calc highlight OB Ovine for ovine or OB Bovine for bovine and press SET 2 Highlight BPD in the submenu and press SET 3 Draw a line segment to measure the BPD 4 The BPD and the GA will be displayed Head Diameter HD measurement Description To measure the head diameter of the embryo Instructions 1 Press Calc highlight OB Feline for feline or Canine for canine and press SET 2 Highlight AC in the submenu and press SET 3 Draw an ellipse refer to Section 4 1 4 4 The HD will be displayed Body Length BD measurement
7. gt to view the next image saved less recently Click lt to view the previous image saved more recently Press Clipboard again or click lt to close the Clipboard window 5 5 Note for Biplane Transducers When using a biplane transducer the system shows ultrasound images for one scan plane by default To view the ultrasound images for the other scan plane press B on the alphanu meric keyboard Press B B to activate the dual display which shows the ultrasound images for the two scan planes simultaneously Since only scan in one plane is possible images in one of the two windows must be frozen Press B on the alphanumeric keyboard to stop scanning the current plane and scan the other plane SonoScape A6V A5V User Manual 55 Transducers This ultrasound system supports a wide range of probes which make the system remarkably versatile This chapter provides the transducer information and the guidance for the use and maintenance of the transducers 6 1 Transducer Information 6 1 1 Supported Transducers and Intended Applications The transducers supported by this ultrasound system are listed non exhaustively in Table 6 1 Model Main applications C351 2 6MHz Convex Abdominal GYN OB C352 2 6MHz Convex Abdominal GYN OB C543 3 8MHz Convex Abdominal Pediatric L745 5 11MHz Linear Small parts L746 5 11MHz Linear Small parts Superficial C312 2 5MHz Micro convex Cardiology C612 4 9MHz
8. 26 A6V A5V User Manual 3 11 Biopsy BodyMark lcardic Juro lother Exit Close Figure 3 15 Bodymark Instructions for adding removing bodymark symbols are shown below Insert In the BodyMark window click an application mode tab to view the corresponding bodymark symbols Click on a symbol to insert the symbol on the ultrasound image Move the trackball to change the probe marker position turn MENU to rotate the probe marker Press SET to end the bodymark insertion Note that inserting a new bodymark symbol also removes the previous one Move Move the cursor over the symbol press ESC A white line box appears around the symbol Move the cursor to the target position and press SET Delete Press BodyMark to re activate the BodyMark window click Exit to close the BodyMark window and remove the bodymark symbol inserted on the ultrasound image Click Close if you do not want to remove the symbol 3 11 Biopsy During the real time scan press MENU to activate the context menu Select Biopsy turn MENU to switch Biopsy on The angle and the position of the biopsy line can be adjusted using the options shown below Biopsy adjustments are shown below Position Highlight Position turn MENU to move the biopsy lines Angle Highlight Angle turn MENU to rotate the biopsy lines SonoScape AGV A5V User Manual 27 3 SYSTEM OPERATION 3 12 Report Figure 3 16 Biopsy In the application mode press Report
9. 4 1 4 for measuring areas 4 1 4 Circumference and Area Description To calculate circumference or area of ellipse or other shapes drawn using the Trace function SonoScape A6V A5V User Manual 37 4 MEASUREMENTS For ellipse 1 Press Calc highlight Area Circ and press SET 2 Highlight Ellipse and press SET 3 Draw a line segment which represents the major axis of the ellipse 4 Use the trackball to change the length of the minor axis and press SET to fix the minor axis 5 The circumference and the area of the ellipse will be displayed If necessary continue to calculate the circumference and area of another ellipse For other shapes 1 Press Calc highlight Area Circ and press SET 2 Highlight Trace and press SET 3 Move the cursor to the start point of trace and press SET Starting from this point move the cursor along the edge of target area Press SET to close the trace the first and last points will be connected with a straight line 4 The circumference of the closed trace and the area enclosed by the trace will be displayed If necessary continue to calculate the circumference and area of another shape Note To prevent calculation error avoid self intersection when drawing the trace 4 1 5 Volume Volume of ovoid can be calculated using 2 Axis or 3 Axis methods 2 Axis Description To measure a globe like volume using one ellipse The following formula is used to calculate the volume A is
10. at mitral valve at end systole LVAMs Left ventricular short axis diameter at end systole LVIDs Left ventricular short axis area at papillary muscle at end LVAPd diastole Left ventricular short axis area at papillary muscle at end systole LVAPs Table 4 1 Measurement items for LV function assessment The following calculation items and formulae are involved 42 SonoScape A6V A5V User Manual 4 2 BMode Advanced Measurements Calculation item Formula Unit End diastolic volume EDV of EDV ml left ventricle End systolic volume ESV of ESV ml left ventricle Stroke volume SV SV EDV ESV ml Cardiac output CO CO SVxHR 1 min Ejection fraction EF EF SV EDV Stroke index SI SI SV BSA Cardiac index CD CI CO BSA 1 min m2 Fractional shortening FS of left ventricle FS LVIDd LVIDs LVIDd Mean ventricular circumfer ence fractional shortening MVCF LVIDd LVIDs LVIDdxET Table 4 2 Calculation items for LV function assessment Where for Asian BSA WTx0 425xHTx0 725x73 58 1000 for European BSA WTx0 425xHTx0 725x71 84 1000 Body weight WT and height HT are expressed in kilograms and centimeters re spectively Measurement and calculation methods for left ventricular available in B mode are Single plane ellipse SPEllipse Bi plane ellipse BPEllipse Bullet Simpson SPEllipse Items to be measured LVALd L
11. current screen 19 FUNC Press this knob to change the current active function Turn this knob to change the parameter of the active function continued on next page SonoScape A6V A5V User Manual 15 3 SYSTEM OPERATION Item Key Description Press this knob to activate the system setup menu or the ul 20 MENU trasound diagnosis context menu Turn this knob to adjust value of the selected parameter in the menu 21 Set This key serves as a confirmation key 22 Distance Measure the distance between two points 93 oe Press this key and draw a closed trace the area enclosed will 23 be automatically calculated and displayed 24 Calc Activate the B mode or the M mode calculation menu 25 Bodymark Insert symbols of body parts 26 Esc Cancel the previous operation or reduce the value of the se 26 lected parameter 27 GAIN Adjust B or M mode gain 28 Freeze Freeze or unfreeze the image 3 5 User Interface Angle Ratio gt area Cir Volune gt gt OB Equine gt GYN gt gt Cardiac gt gt URO gt gt E v Figure 3 2 User interface of application mode The user interface of the application mode is shown in Figure 3 2 It can be divided into 8 areas showing the following information 1 Nas AM Logo Image information Measurement and calculation results Context menu Patient information system time and etc Ultrasound image TGC curve and grays
12. e For the proper disposal of this product at the end of its lifetime contact SonoScape or local representative of SonoScape 1 2 Symbols Symbol Description Dangerous electric voltage Warning Follow these instructions to avoid personal injury or sys tem damage Attention Follow these instructions to avoid system damage On Main power switch ON Protective earth ground connection Potential equilibrium connection AC Type B applied part A A A O Off Main power switch OFF Y li Non ionization radiation Ultrasound scanner transmits acoustic waves Warning Do not use the system with the presence of inflammable gases including inflammable anesthetics 1 3 Ultrasound Safety In order to discuss about ultrasound safety the biological effects associated with the ul trasound should be understood first Note that it s the user s responsibility to properly interpret the output display and avoid unnecessarily exposing the patient to ultrasound energy Subsection 1 3 1 discusses the mechanisms that generates the biological effects and the output display including the output indices Subsection 1 3 2 discusses the guideline cited from AIUM and recommended by FDA SonoScape 2 A6V A5V User Manual 1 3 Ultrasound Safety 1 3 1 Biological Effects The following two biological effects should be thoroughly understood by the user Heating ther
13. in the EXAM interface To delete an exam mode select a user defined exam mode in Figure 5 1 and click Delete You can only delete user defined exam modes To export User Defined Exam Modes to an external USB drive insert the USB drive into the USB port of the ultrasound system then click Export to USB The user can provide a name 53 5 SAVING REVIEWING for the backup file e g XX The system will backup all exam modes to a single file with the file name USEREXAM XX uem and save it on the USB drive To import User Defined Exam Modes from an external USB drive insert the USB drive with the uem file click on the Import from USB button to import the User Defined Exam Modes from the USB drive 5 1 2 Saving Images In freeze mode press SAVE to activate the Save Image window Click Exit to close the window Or click other buttons to save images or cine The meaning of these buttons are explained below Figure 5 2 Save images and video Single Image Click this button to save the image in DCM JPEG or BMP format The image will be saved into either the patient folder which is named with the patient ID or if no patient profile is active the root directory on the system drive Frame Image Click this button to save the image in FRM format The image will be saved into either the patient folder or if no patient profile is active the root directory on the system drive AVI Movie Click this button to save the cin
14. of ultrasound images with higher resolution and has more grayscale levels and it also weighs less reducing the weight of the whole ultrasound system Software updates are provided regularly Upgrades can be done effortlessly through the standard IO ports thanks to the use of specialized and versatile operating system in use 7 2 SYSTEM DESCRIPTION 2 2 Applications This system uses electronic scan and has a large selection of supported broadband trans ducers Equipped with these transducers the system is suitable for most clinical ultrasound diagnoses Some typical applications are listed below e Small parts breast thyroid testes etc e Gynecology e Obstetrics equine feline ovine bovine and canine e Cardiology e Urology 2 3 Contraindication The system is not intended for OPHTHALMIC use or any use that causes the acoustic beam to pass through the eye s SonoScape 8 A6V A5V User Manual 2 4 System Configuration 2 4 System Configuration 1 RS232 port 3 VGA port 2 Ethernet port 4 S VIDEO port 5 Two USB ports SonoScape A6V A5V User Manual 2 SYSTEM DESCRIPTION 1 PULTE TTF gt DOA 7 co y 1 Video Printer Controller 2 S VIDEO Port Port 3 Foot switch port 4 Ground point 5 Mains power input 6 Power switch socket 7 Probe connection ports 8 Two probe holders 2 4 1 Standard Configuration Main unit 1 pe Power cable 1 pe Transducer
15. selection At the System Setting window click Formula Select to activate the formula selection window Select the formulae from the drop down lists Click LoadDefault to load the default for mulae for all measurement items Click Save to save the settings and exit Click Exit to exit without saving 3 6 4 Formula Define At the System Setting window click Formula Define to activate the Formula Define win dow You can create new formula tables here SonoScape A6V A5V User Manual 19 3 SYSTEM OPERATION AAA i MEINE mi il tial al Figure 3 7 Create formula table Item Select the measurement item to be edited from the dropdown list Formula Select the formula table that your new table will be based on Meas The measurement values should be set from the minimum to the maximum and can have up to 32 different values GA Set the respective GA values at the corresponding distance Save To save the formula table click this button and enter a name in the popup dialog box The system automatically adds U in front of the name Exit Discard changes and exit Delete Delete the selected formula table Only the user defined formula table can be deleted 3 6 5 Comment Setting At the System Setting window click Comment Setting to activate the Comment Define window Figure 3 8 Comment Define customize annotation items SonoScape 20 A6V A5V User Manual 3 6 System Setting The Comment Sett
16. to activate the Report window see Figure 3 17 Click Exit to close the window The operation of Report is shown below Save PrinterSet Print and PDF export 3 13 Peripherals 3 13 1 USB Devices Click Save and enter a name in the popup window to save the report You can use the Disk Management to review the saved report files Click PrinterSet and select the appropriate printer model HP Color LaserJet cP1518 gt Click Print to activate the Print window see Figure 3 18 You may add the doctor s comments and the ultrasound images into the report here Click Print to print out the report Click SaveReport to export the report in PDF format Using the generic USB connection the system supports many peripherals including remov able disk drive CD writer USB mouse and etc amp Note We recommend using branded USB drives Kingston for example for patient data storage Certain devices e g external CD DVD writers may draw large electric current please provide these devices with independent power supply 28 SonoScape A6V A5V User Manual 3 13 Peripherals Figure 3 18 Print report SonoScape A6V A5V User Manual 29 3 SYSTEM OPERATION Guidance for using external USB devices USB disk drives USB disk drives includes flash drives and removable hard drives When a USB disk drive is connected the icon gt appears at the bottom right corner of the screen Use the Disk Manag
17. 6601 1 1990 A1 1993 A2 1995 continuous operation Avoid using the system in the presence of inflammable gases esp inflammable anes thetics SonoScape A6V A5V User Manual 1 7 Electrical Safety Classification e Degrees of protection against harmful liquid For the main system IPXO For the transducer IPX7 from the acoustic window to the junction line Figure 6 1 and IPX1 for other parts that may contact with the patient excluding the transducer connector e This system conforms with the following EMC EMI standards IEC60601 1 2 2001 A1 2004 Class A CE Protective earth should be used to protect the system from AC power supply interfer ences SonoScape A6V A5V User Manual 5 System Description 2 1 General Figure 2 1 System Overview This ultrasound system is a full digital B W diagnostic ultrasound equipment with high performance With the state of the art design and the utilization of high performance su per large scale integration SLSI this system is extremely capable of acquiring the acoustic information of human tissues Accompanying the advanced hardware design is the Linux system specifically optimized for medical use it serves as the solid back end for a wide range of professional medical application packages and the ease of use graphical user in terface GUI Compared to the conventional LCD monitors the industrial grade LCD monitor installed on the system supports the display
18. AAMP Highlight DESLP and press SET Perform a standard M mode distance measurement to measure DESLP Highlight EFSLP and press SET Perform a standard M mode distance measurement to measure EFSLP 3 The measurement and calculation results will be displayed Aortic Valve AV Figure 4 7 AV measurements The following items will be measured in the AV measurement AOD Aortic diameter LAD Left atrium diameter AVD Aortic valve bore diameter ET Ejection time RVOTD Right ventricular outflow tract diameter AA Aortic amplitude The following items will be calculated Item Description Formula LA AO Left atrium aorta ratio LAD AOD AVSV Aortic valve stroke volume MAVO1 MAVO2 Where MAVO1 and AA are Instructions 1 In M mode or B M mode press Calc highlight AV and press SET 2 Highlight AOD and press SET Perform a standard M mode distance measurement to measure AOD 3 Highlight LAD and press SET Perform a standard M mode distance measurement to measure LAD SonoScape A6V A5V User Manual 51 4 MEASUREMENTS 4 Highlight AVD and press SET Perform a standard M mode distance measurement to measure AVD Highlight ET and press SET Perform a standard time measurement to measure ET 6 Highlight RVOTD and press SET Perform a standard M mode distance measurement to measure RVOTD 7 Highlight AA and press SET Perform a standard M mode distance measurement to measure AA 8 The measurement and calcul
19. F AS STA e ar AAA ricas La pa G 28 3 13 2 Foot Switch aus 6 eee kao EO ek Re A A wa AE 30 3 133 Video Out ssa rasa dede E q e Seen eid ala 30 3 13 4 Network Devices sus una A A ERS 30 3 14 TMA SITS ss encare alba ae braile tanta cada AAA Dh gh Be see qa a ok tena es eee Se 30 3 14 1 Basic Operation sussa sumos SO E E Se SS eR 30 3 14 2 Parameter Adjustment 02 020 ee ee ee eee 31 SPAS ZOOM iate opta Pies Bi Riis ne ara Nec ee SO ae Peed dE a E as Pi O na 33 4 Measurements 35 4 1 B Mode Basic Measurements 2 0 00 eee eee eae 35 4 1 1 Distance 2 ssa eta E A SE ee Ve 35 Ali Angle rsss wie a le ae OG aoe eS 35 ALS RAMO 2 2 2h DA A ae Bch te ae eta at e De dd Be 37 4 1 4 Circumference and Area 37 AMS VOTES ques as a Wa Cae ieee Oe wee y e e 38 4 2 B Mode Advanced Measurements 2 0 00 eee eee 39 4 2 1 OBMeasurements 0 2 0 0 eee eee ee ee ee ee 39 4 2 2 Gynecology Measurements GYN o o 40 4 2 3 Cardiology Measurements o 42 4 2 4 Urology Measurements e 45 4 2 5 Small Part Measurements 46 4 3 M Mode Measurements a 47 4 3 1 M Mode Basic Measurements 47 4 3 2 M Mode Advanced Measurements eee 49 5 Saving Reviewing 53 SF SAVING sori gS Sm aa ea eR OR Bo ee RAW ie E e 53 5 1 1 Saving User defined Exam Mode
20. IVSTd at end diastole Left ventricular wall thickness of the posterior wall at end dias LVPWd tole Left ventricular wall thickness of the inter ventricular septum IVSTs at end systole Left ventricular wall thickness of the posterior wall at end sys LVPWs tole Table 4 3 Measurement and calculation items for LV assessment in M mode Teichholz formula Items to be measured LVIDd LVIDs ET Items to be calculated EDV ESV SV CO EF SI CI MVCF FS Formula 7 x LVIDd EDV gt x 2 4 LVIDd 7 x LVIDs ESV 200 cad 2 4 LVIDs Measurement instructions ga AUN Press Calc highlight LV and press SET Highlight TEICHHOLZ and press SET Draw a line segment to measure LVIDd Draw a line segment to measure LVIDs Perform a standard time measurement to measure ET The measurement and calculation results will be displayed Cube formula Items to be measured IVSTd LVIDd LVPWd IVSTs LVIDs LVPWs ET Items to be calculated EDV ESV SV CO EF SI CI MVCF FS Formula EDV LVIDd ESV LVIDs SonoScape A6V A5V User Manual 49 4 MEASUREMENTS Measurement instructions OMAN DU AWNHEH E o Press Calc highlight LV and press SET Highlight CUBE and press SET Draw a line segment to measure IVSTd Draw a line segment to measure LVIDd Draw a line segment to measure LVPWd Re scan the patient in the appropriate plane Dr
21. Micro convex Pediatric Veterinary 6V5 4 9MHz TV Micro convex GYN EC2 4 9MHz EC Micro convex Endocavitary Table 6 1 Transducer list 6 2 Environmental Requirements The transducers should be used with that the following environmental requirements has been satisfied Operation Storage and transport Relative humidity 30 75 no condensation 20 90 no condensation Ambient tempera 10 C 40 C 20 C 55 C ture Barometric pressure 700hPa 1060hPa 700hPa 1060hPa 57 6 TRANSDUCERS 6 3 Preparation and Usage of the Probe 6 3 1 Inspection After each use or before first use or after long time storage of the probe the probe must be examined for any damages listed in the table below Stop using the probe if any damage is found Contact your representative for servicing asap Possible damage types Cracks on the probe handle user section Cracks on the probe head applied section Scratches on the probe head acoustic window surface Swell of the acoustic window material Cracks or wear on the probe cable Cracks on the probe connector or any other kinds of visible damage Deformed pins or broken pins exist inside the probe connectors 6 3 2 Probe Connection Refer to Section 3 2 for detailed information on probe connection 6 3 3 Preparation for Scanning A Attention e An effective acoustic coupling does not require inordinate pressure but it does require coupling gel and patient contac
22. Revision History Revision History Revision Date Reason for change 1 0 July 2009 Initial release of product Compiled on May 6 2011 P N 4710 00043A01 1 Caution Caution e This manual contains necessary information to operate the system safely Please read this manual before attempting to use the system e Read Chapter 1 first Review this chapter before start operating this system e Due to frequent software update your system may be configured slightly differently from what are introduced in this book Regulatory Requirement This product complies with regulatory requirements of the following European directive LVD amp EMC Ce SonoScape 2 A6V A5V User Manual Contents Contents i 1 System Safety 1 1 1 Safety Overview o es 1 LIZ Symboli voice rl a A e ada o x 2 1 3 Ultrasound Safety sus a are a a ll aes 2 ESL Biological Effects 00 e EE a oa eS E DG A ice tes 3 1 3 2 ALARA Principle of Diagnostic Ultrasound 3 1 4 Requirements for Operation e eee eee 4 1 5 Environmental Requirements for Transport and Storage 4 1 6 Electrical Requirements 4 1 7 Electrical Safety Classification 4 2 System Description 7 QTE General stayed at o o Age se ee eG A A a da EE IS 7 2 2 ADPIC as a nm aaa SA ee ee ae Ae eee 8 2 3 Contr
23. Scan the patient in the appropriate plane Press Calc highlight Small Part and press SET Highlight P Thyroid and press SET Draw a line segment to measure Length Draw a line segment to measure Width Draw a line segment to measure Height The measurement and calculation results will be displayed NO 1 fh WN 4 3 M Mode Measurements The measurements available in M and B M modes are shown in Figure 4 5 4 3 1 M Mode Basic Measurements Distance Measurement in M Mode Description To measure the distance between two points on the M mode image Instructions 1 In M mode or B M mode press Calc highlight Distance and press SET 2 Move the cursor to the start point and press SET 3 Move the cursor to the end point and press SET 4 The measurement result will be displayed If necessary continue to measure another distance in the same manner Time Measurement Description To measure the time between two points on the M mode image Instructions SonoScape A6V A5V User Manual 47 4 MEASUREMENTS Calc Slope Heart Rate LU MU Cube Teichholz Gibson Tei Index Calc LUIDd LUPWd UNE LUIDs LUPWs Haia CAAMP DEAMP DESLP Figure 4 5 M mode measurement and calculation menus 1 In M mode or B M mode press Calc highlight Time and press SET Move the cursor to the start point and press SET 3 Move the cursor to the end point only ho
24. Section 3 6 2 3 14 Imaging 3 14 1 Basic Operation The system supports the following imaging modes B 2B 4B B M dual mode and sin gle M mode and Tissue Harmonic Imaging THD During the real time scan these basic operations are possible B mode Press B the B mode key to activate the single B mode which is the default imaging mode SonoScape 30 A6V A5V User Manual 3 14 Imaging 2B mode 4B mode B M mode THI mode Flip horizontally Flip vertically Press B B to activate the 2B mode the image on the left is active Press this key again to make the image on the right active and freeze the image on the left Press 4B sie to activate the 4B mode or quad display mode Use 4B to change the active ultrasound image Press B M to activate the B M dual mode Use B M to choose the full M mode display or the B M dual display The BM Format in Figure 3 4 sets the layout in the B M dual mode Press THI to activate or deactivate the Tissue Harmonic Imaging Press L R amp to flip the active ultrasound image horizontally Press Up Down em to flip the active ultrasound image verti cally 3 14 2 Parameter Adjustment The following parameters are adjustable irrespective of the imaging mode Frequency Depth Focal position Zoom Context menu Gain Time Gain Compensa tion TGC Press Freq to change the ultrasound frequency of the transducer Press FUNC several times until the Dept
25. VLd LVALs LVLs Items to be calculated EDV ESV SV CO EF SI CI Formula 8 LVALd EDV SS LVL 8 LVALs EO INTE Measurement instructions ON aA Us 9 Scan the patient in the appropriate plane Press Calc highlight Cardiac and press SET Highlight LV and press SET to open the submenu highlight S Plane in the submenu and press SET Measure LVALd refer to Section 4 1 4 for instructions Measure LVLd refer to Section 4 1 1 for instructions Re scan the patient in the appropriate plane Measure LVALs refer to Section 4 1 4 for instructions Measure LVLs refer to Section 4 1 1 for instructions The measurement and calculation results will be displayed BPEllipse SonoScape A6V A5V User Manual 43 4 MEASUREMENTS Items to be measured LVALd LVAMd LVIDd LVALs LVAMs LVIDs Items to be calculated EDV ESV SV CO EF SI CI Formula EDV 8 ILVALd x LVAMd 3 a x LVIDd M psy 5 x LVALs x LVAMs 3 m x LVIDs Measurement instructions 1 Scan the patient in the appropriate plane 2 Press Calc highlight Cardiac and press SET 3 Highlight LV and press SET to open the submenu highlight B Plane in the submenu and press SET Measure LVALd refer to Section 4 1 4 for instructions Measure LVAMd refer to Section 4 1 4 for instructions Measure LVIDd refer to Section 4 1 1 for instructions Re scan the patient in the appropriate plane Measure LVALs refer
26. aindication e 8 2 4 System Configuration 0 0 0 2 eee eee ee ee ee 9 2 4 1 Standard Configuration 2 0 0 ee ee ee eee 10 2 4 2 Optional Accessories 2 2 2 ee ee ee 10 2 4 3 Optional Peripherals 11 3 System Operation 13 3 1 Op ration Notice qua a ote eA ae SG lee we EE he RE eS 13 3 2 Transducer Connection e 13 3 3 Power ONZOFE sia do ap id Gs DOS oe ee Ae ee eS ee Gee rast 13 3 4 Keyboard Functions e 14 3 5 User Itaca eee see a YE oe a E e E aE 16 3 6 System Setting ua ea e s a ee ted A A ee ee a 17 3 6 1 General Setting wi css ee a ee a a eae e 17 310 2 DICOM Setting coa ae alee o dee GEA ee See Be eh a ed eee 18 3 6 3 Formula Select o 0 eee ee ee a a ee 19 3 6 4 Formula Define e ee ee ens 19 3 6 5 Comment Setting 2 0 e 20 3 6 6 System Update sa amarei a A eee BEE a a 21 3 7 Patient Information eee ee ee eee 22 3 8 Add Comments Annotations o ee ee ee eee 23 3 9 Disk Management sus asas ela Ea ae ee SO eG 23 3 9 1 FileBurning cccccccll ee ee 26 CONTENTS 3 10 Bodymark aus a AA SS ES ASR a OS 26 STEBI a 2 8 2 A Meecha Pal A E oh te q qa RA RCE ee oe Si Sa ag Ce Pd A 27 3 12 REPORT sro a Goa RUE E EA OR ee G 28 3 13 Peripherals ss sensu aa DO RO UR DS SS NG A VA O PA 28 5 13 1 USB Devices e aeara ad E
27. al 23 3 SYSTEM OPERATION 90012 6 a 25 3 2800 81 24 0001 mp 470 KB 2000 01 0001 mp 47 2000 91 00012 a 25 2000 01 9001 mp 478 KB 2000 68612 mp 478 K 2000 91 24 66612 a 256 KB 2000 01 24 000124 mp 47 2000 01 21 000124 a 25 2000 0001 a 256 2000 90012 5 bmp 47 2008 8 860124 24 m 256 KB 2098 6661176 mp 17 2990 900117090421 Figure 3 12 Data management Disk Management window consists of 5 areas showing the following information 1 The current disk drive the working path and the disk usage information Operations can be applied to directories and files File folders in current directory Files in current directory Other operations meN 2 Hint Use ESC instead of SET to select multiple files or file folders Instructions for using Disk Management are shown below Drive Select a disk drive from the dropdown list to open The current working path and the disk usage information are also shown in this row Operations applied to directories NewDir Click this button and enter a name to create a new directory file folder Copy and Paste Select a file folder click Copy Go to the target directory and click Paste to paste the folder into the directory SonoScape 24 A6V A5V User Manual 3 9 Disk Management Delete Select a file folder click this button to delete it Rename Click it to rename the selected file folder Two file folders must not have the same name Parent Directory Click
28. ation results will be displayed q Tei Index Description To calculate the Tei index by measuring the isovolumic contraction time ICT the ejection time ET and the isovolumic relaxation time IRT and using the fol lowing fomula TEI ICT IRT ET Instructions 1 In M mode or B M mode press Calc highlight Tei Index and press SET 2 Highlight ICT and press SET Perform a standard time measurement to measure ICT 3 Highlight IRT and press SET Perform a standard time measurement to measure IRT 4 The measurement and calculation results will be displayed Cardiology Report Description To activate the Report window for writing cardiology report Refer to Sec tion 3 12 SonoScape 52 A6V A5V User Manual Saving Reviewing 5 1 Saving To save a customized exam mode see Subsection 5 1 1 To save images see Subsection 5 1 2 5 1 1 Saving User defined Exam Mode Exam modes can be customized and saved and can also be imported from or export to external drives Follow instructions below to customize and save an exam mode Figure 5 1 Save customized exam mode Select a probe and an exam mode for the probe Press Set to start a real time scan Adjust the various parameters for the exam mode Press SAVE to open the Exam Define window see Figure 5 1 A N re Select the type of application from the dropdown list Click Save and enter a new name The icon for this exam mode now appears
29. aw a line segment to measure LVIDs Draw a line segment to measure LVPWs Perform a time measurement page 47 to measure ET The measurement and calculation results will be displayed Gibson formula Items to be measured LVIDd LVIDs ET Items to be calculated EDV ESV SV CO EF SI CI MVCF FS Formulae EDV x 0 98 x LVIDd 5 90 x LVIDd ESV x 1 14 x LVIDs 4 18 x LVIDs Measurement instructions ak WwW Nd Press Calc highlight LV and press SET Highlight GIBSON and press SET Draw a line segment to measure LVIDd Draw a line segment to measure LVIDs Perform a time measurement to measure ET The measurement and calculation results will be displayed Mitral Valve MV Mitral Valve Figure 4 6 MV measurements Description To measure the E wave amplitude CEAMP DE wave amplitude DEAMP A wave amplitude CAAMP mitral valve opening speed DESLP and mitral valve closing speed EFSLP and to calculate the ratio of A wave and E wave A E Instructions 50 SonoScape A6V A5V User Manual 4 3 M Mode Measurements 1 In M mode or B M mode press Calc highlight MV and press SET 2 Highlight CEAMP and press SET Perform a standard M mode distance measurement to measure CEAMP Highlight DEAMP and press SET Perform a standard M mode distance measurement to measure DEAMP Highlight CAAMP and press SET Perform a standard M mode distance measurement to measure C
30. cale bar Notification area it displays the notification for current operation USB connection status and etc 16 SonoScape A6V A5V User Manual 3 6 System Setting 3 6 System Setting In the preparation mode EXAM screen press MENU to activate the System Setting in terface Press MENU again or click Exit to close the System Setting window Figure 3 3 System Setting The rest of this section explains how to customize the system using the items listed in the System Setting interface 3 6 1 General Setting At the System Setting window click General Setting to activate the General Setting window Figure 3 4 General Setting The options in General Setting are explained below Hospital Name Type in the hospital or department name with no more than 40 characters SonoScape A6V A5V User Manual 17 3 SYSTEM OPERATION Date Enter the date in the YYYMMDD format Time Enter the time in the HHMMSS format Language Select the language of the GUI from the dropdown list You need to restart the system for the change to take effect Screen Save Change the time to wait before the screen saver starts Set to OFF to disable the screen saver BM Format From this dropdown list select the default layout used in the B M dual mode Image Set Set the image format for saving JPG BMP or DCM Video Set Set the analog video encoding system to NTSC or PAL Menu Set Menus can be set to appear in grayscale
31. e sequence as AVI movie At most 512 frames can be saved Note that the AVI movie can only be saved into external USB disk drive Cine Image Click this button to save the cine sequence in CINE format At most 512 frames can be saved Note that the cine can only be saved to external USB disk drive Shortcut Keys In cine mode press M to save bmp image press J to save jpg image press F to save frm image press D to save dcm image 5 2 Cine Review Press FREEZE during a real time scan to freeze the image and start the cine mode At most 512 frames can be recalled SonoScape 54 A6V A5V User Manual 5 3 M Mode Cine Review Frame by frame review In cine mode move the trackball slowly to review the cine loop frame by frame The frame number for the current frame is shown at the cine playback status bar Cine loop playback In cine mode move the trackball fast forward to start the cine loop playback Move the trackball again to stop the playback 5 3 M Mode Cine Review Operations for the cine review in M mode are the same as in B mode In B M duplex cine mode the B mode image and the M mode trace are updated simulta neously 5 4 Clipboard In cine mode press Clipboard to start the clipboard tool which provides quick assess to the saved images The Clipboard shows five thumbnails of the most recently saved images Move the trackball to look for the images saved even earlier Figure 5 3 Clipboard Click
32. een 2 Patient Access the Patient Information interface 3 Comment Insert comments 4 File Go to disk management system 5 Clipboard Go to clipboard function 6 THI Tissue Harmonic Imaging 7 Freq Change transducer frequency Alphanumeric key 8 board Input characters or numbers Press Clear to clear the screen oa continued on next page SonoScape 14 A6V A5V User Manual 3 4 Keyboard Functions D DO 0 aa Mm e TOC ojo E tea N Exam Patient Comment File Clipboard THI Freq 42 13 Pa Es 6 7 8 Co o Backspace Clear a w FR E ly u i to lp J 8 bica ae Caps Lock s o Fl ela fol PK Te enter O Shift NA civi BI N M Space ni 10 11 12 19 20 ERI A s a Bla Up Down D 23 24 E wm Se La ay e La ES EY EA qem do T 15 soe SE Os 16 17 e A Report 21 26 GAIN 28 18 set Esc Print Freeze Figure 3 1 Control panel Item Key Description 9 TGC Adjust variable gain of the amplification applied to the echoes 10 B Return to B Mode an B Activate the dual B mode or switch the selection to be acti vated between left and right 12 Up Down Flip the image vertically 13 B M Switch between B M and full M mode 14 4B 4B mode 15 L R Flip the image horizontally 16 SAVE Save application mode or save image or cine 17 REPORT Activate the REPORT interface 18 Print Print the
33. ement window to copy move or delete files into or from the USB drive USB drives can be removed after closing the Disk Management window External CD DVD Connect an external CD DVD writer to the system using the USB writer connection Refer to Section 3 9 for burning data to CD DVD USB printer Connect a printer supported by the ultrasound system using USB cable The icon lt appears at the bottom right corner of the screen Press Print and make adjustments in the Print dialog Click Confirm to send the data to the printer 3 13 2 Foot Switch Foot switch is ready to use after connected to the ultrasound system 3 13 3 Video Out The ultrasound system has the following connectors on board VGA S VIDEO and a Com posite Video connector Ultrasound images can be easily displayed on other external mon itors using these connectors The most popular standards for Composite video the format for the analog television signal are NTSC and PAL Depending on your geographical location you may be using one of the two standards make the configuration accordingly Refer to Section 3 6 1 for instructions To use the video printer connect it to the Composite Video port using the composite video cable and to the remote control port using the remote control cable Press Print to trigger the remote video printing 3 13 4 Network Devices Connect the device to the ultrasound system using LAN cable for more configuration de tails refer to
34. ent thickness of the endometrium will be displayed Volume of Left and Right Ovaries L Ovary R Ovary Description To measure the length width and height of the left and right ovaries and calculate the volume of the left and right ovaries The volume of the ovaries is calculated using the following formula For left ovary L OV V 0 523 x LtL mm x LtH mm x LtW mm For right ovary R OV V 0 523 x RtL mm x RtH mm x RW mm Instructions 1 Press Calc highlight GYN and press SET Highlight L Ovary or R Ovary in the submenu and press SET Draw a line segment to measure the length of the left or right ovary Continue to measure the width and height of the left or right ovary The measurement results and the left or right ovary volume will be displayed dga AUN Ovary Follicles Two Distances L Follicle 2 R Follicle 2 Description To measure the left and right ovary follicles with two distances Instructions 1 Press Calc highlight GYN and press SET 2 Highlight L Follicle 2 for measuring the left follicle or R Follicle 2 for measuring the right follicle press SET 3 Draw a line segment to measure the first distance 4 Continue to measure the next distance in the same manner 5 The measurement results will be displayed Ovary Follicles Three Distances L Follicle 3 R Follicle 3 Description To measure the left and right ovary follicles with three distances Instructi
35. ery EDD will be calculated from LMP and be displayed Comment Enter comments here You can type up to 80 characters More Click this button to expand the Patient Information window and enter more detailed information about the patient Click this but ton again to collapse the Patient Information window 3 8 Add Comments Annotations In the application mode either during the real time scan or with the frozen image press COMMENT to start the annotation mode Press this key again to exit the annotation mode Figure 3 11 Annotation selection Operations available in the annotation mode are explained below Manual Edit In the annotation mode typed text will be inserted at the cursor position Insert Predefined In the annotation mode press ESC to activate the annotation item String selection window see Figure 3 11 Click an item to add the item on the ultrasound image Move Annotation Move the cursor over an annotation item when the cursor changes to press SET Move the cursor to a new position and press SET to place the annotation item there Delete Annotation Move the cursor over an annotation item press Backspace to delete the item Press Clear to remove all annotation items from the ultrasound image 3 9 Disk Management Use Disk Management to manage the data both on the local and external drives Press File to activate the Disk Management window To exit press File again SonoScape A6V A5V User Manu
36. h function is active The active function attached to FUNC is displayed at the notification area at the bottom of the screen Turn FUNC to change the max imum imaging depth Press FUNC several times until the Focus function is active Turn FUNC to change the Focal position Press FUNC several times until the Zoom function is active Refer to Subsection 3 14 3 for instructions Press MENU to activate or deactivate the context menu Move the trackball to select items in the menu Turn MENU to change the value of the selected item Press Gain to attach this knob to the B mode gain or the M mode gain Turn Gain to change the B mode gain or the M mode gain Slide the TGC controls to change the compensations at the dif ferent depths The TGC curve disappears automatically after 3 seconds and re appears once the TGC controls are changed The following B mode imaging parameters are possible Power BPWR Frequency BFREQ Focal Number PTN Focal Span SPAN The acoustic output power keep it as small as possible The ultrasound frequency generated by the transducer The number of focal zones The span of the focal zones Makes sense only if multiple focal zones are present SonoScape A6V A5V User Manual 31 3 SYSTEM OPERATION Image BPWR BFREQ PTN SPAN REGION o lt z PER ENH T High 70 3 5 4 5 MSMO REGION Figure 3 19 Context menus of B mode left and M mode right Line Densit
37. iate plane Press Calc highlight URO and press SET Highlight RUV and press SET Draw a line segment to measure Length Draw a line segment to measure Width Draw a line segment to measure Height 7 The measurement and calculation results will be displayed Au BwWN SonoScape A6V A5V User Manual 45 4 MEASUREMENTS Prostate Volume PV Description To measure the three axial distances D1 D2 D3 of the prostate and estimate the prostate volume D1 anteroposterior diameter D2 longitudinal diameter D3 transverse diameter Prostate Volume PV a x D1 x D2 x D3 Prostate specific antigen density PSAD PSA PV Where PSA or the prostate specific antigen is expressed in ng User can provide this value or otherwise it is PSA 0 12 x PV Instructions 1 Scan the patient in the appropriate plane Press Calc highlight URO and press SET Highlight PV and press SET Draw a line segment to measure Length Draw a line segment to measure Width Draw a line segment to measure Height 7 The measurement and calculation results will be displayed Anu AUN Left and Right Kidney Volumes Description To measure the three axial distances D1 D2 D3 of the left or right kidney and estimate the left or right kidney volume Kidney Volume amp x D1 x D2 x D3 Instructions 1 Scan the patient in the appropriate plane 2 Press Calc highlight URO and pres
38. ient skin Use of sterile legally marketed probe sheath is re 4 Cover the probe with the probe sheath up to the user section probe handle 5 Examine the integrity of the probe sheath If breakage occurs repeat from step 1 to replace the sheath with another new one 6 3 4 Scanning Refer to Chapter 3 to turn on the system and start an ultrasound diagnosis 6 4 Probe Maintenance Cleaning and Disinfection Clean the transducer and the probe handle after each use For surface probes disinfect the transducer periodically For intracavitary probes disin fecting the transducer after each use is required Keep a log of maintenance inspection cleaning and disinfection and malfunction 6 4 1 Probe immersion level E i Cable e L745 Cable Sheath A C351 LX LN Probe Handle Junction Junction e N Line ai aa v an iii J Transducer Figure 6 2 Intracavitary Figure 6 1 Surface probes probe For surface probes do not immerse the probe beyond its junction line refer to Figure 6 1 For intracavitary probes the allowed immersion level is shown in Figure 6 2 SonoScape A6V A5V User Manual 59 6 TRANSDUCERS A Warning e DO NOT use solutions containing alcohol mineral oil for cleaning or dis infecting probes e Wear medical sterile gloves to prevent potential disease transmission Wear protective goggle if necessary e DO NOT apply solution
39. ind of do it yourself repairs invalidate the warranty Contact your representative for service instead 7 2 Manufacturer Responsibility The manufacturer assumes the responsibility with regard to safety reliability and perfor mance of this product only under the following conditions e all installation hardware and software upgrades modifications and repairs of this product are performed or instructed by authorized personnel e Operation transport and storage of this product are under the required environmental conditions e the product is operated in accordance with this user manual 61 7 SYSTEM MAINTENANCE 7 3 Contact Information Any feedbacks or inquires concerning our product or service should be directed to the following address E Contact Information Address 4 F Yizhe Building Yuquan Road Shenzhen P R China Zip Code 518051 Tel 86 400 678 8019 Fax 86 755 26722850 Website http www sonoscape com E mail service sonoscape net 62 SonoScape A6V A5V User Manual A Information of EU Representative SONOMED Via Luigino Tandura 74 00128 Rome Italy Tel 39 06 5082160 Fax 39 06 5084752 63
40. ing window can be divided into the following 4 areas 1 Tabs of application modes 2 Predefined annotations 3 User defined annotations User can add at most 6 annotation items 4 User operations The instructions for adding and removing the annotation items are shown below Selection Click a user defined annotation item to select it Edit Modify the string using the alphanumeric keyboard ADD Add the string as a new user defined annotation item DEL Delete the selected annotation item Exit Exit the Comment Define window 3 6 6 System Update You can update the system using USB connection Take the following precautions before update e Power supply must not be interrupted while updating the system e Do not disconnect the USB drive during the system update e The USB drive for system update must be USB 2 0 compatible The USB drive should contain only the update files which must be saved in the root directory Figure 3 9 System update Follow these procedures to update the system 1 Save the update files in the root directory of the USB drive 2 Turn on the ultrasound system When the EXAM screen appears press MENU to activate the System Setting window 3 Click System Update enter the password aaaaaa by default and press OK to open the System Update window 4 Select the parts to be updated refer to Figure 3 9 and click Update to start updating the system This step takes about 10 minutes 5 When the curs
41. mal effect Elevating tissue temperature during obstetrical examinations creates medical concerns At the embryo development stage the rise in temperature and the length of time exposed to heat combine to determine potential detrimental effects Exercise caution particularly during Doppler Color exams The Thermal Index TT provides a statistical estimate of the potential temperature elevation in centigrade of tissue temperature Three forms of TI are available TIS for soft tissue exposures TIB for instances when bone lies near the beam focus and TIC for the heating of bone situated close to the transducer Cavitation mechanical effect Cavitation may occur when sound passes through an area that contains cavities such as gas filled bubbles or air pocket in the lung or intestine for example During the process of cavitation the sound wave may cause the bubble to contract or resonate This oscillation may cause the bubbles to rupture and damage the tissue The Mechanical Index MI has been created to help users accurately evaluate the likelihood of cavitation and the related adverse effects It should be noticed that the acoustic output and the thermal and mechanical indices vary with some parameters such as the number of focal zones the depth of focus the choice of B mode M mode or Doppler mode and etc 1 3 2 ALARA Principle of Diagnostic Ultrasound Exposure time and acoustic output applied to the patient should be limi
42. ons 1 Press Calc highlight GYN and press SET 2 Highlight L Follicle 3 for measuring the left follicle or R Follicle 3 for measuring the right follicle press SET 3 Draw a line segment to measure the first distance 4 Continue to measure the next two distances in the same manner SonoScape A6V A5V User Manual 41 4 MEASUREMENTS 5 The measurement results will be displayed Cervix Description To measure the length width and height of the cervix Instructions 1 Press Calc highlight GYN and press SET Highlight Cervix and press SET Draw a line segment to measure the length of the cervix ak UUN The measurement results will be displayed Gynecology Report Continue to measure the next two distances in the same manner Description To activate the Gynecology Report window It is equivalent as pressing Report see Section 3 12 4 2 3 Cardiology Measurements Left Ventricular LV Function Assessment The measurement items for assessing left ventricular function are listed below Left ventricular long axis area at end diastole LVALd Left ventricular long axis length at end diastole LVLd Left ventricular long axis area at end systole LVALs Left ventricular long axis length at end systole LVLs Left ventricular short axis area at mitral valve at end diastole LVAMd Left ventricular short axis diameter at end diastole LVIDd Left ventricular short axis area
43. or changes back to its arrow like shape you should restart the system 6 After the restart re open the System Update window 7 Select only Update Config and click System Update to update the configuration file 8 Restart the system after the update completes SonoScape A6V A5V User Manual 21 3 SYSTEM OPERATION A Attention To find the system information including the software version number see Sub section 3 6 1 For new users please update the system only under the guid ance of our service engineers 3 7 Patient Information Press Patient to activate the Patient Information window Click Save to save the current patient information Click Exit exit without saving changes Figure 3 10 Patient Information The Patient Information window comprises the following information Name Type the name of the patient here Sex The gender of the patient Height The height of the patient in centimeters ID The patient ID can be combinations of letters and numbers Age The age of the patient must have no more than 3 digits Weight The weight of the patient in kilograms Clinic No Keep the length less than 10 characters Bed No The Bed No must have no more than 3 digits LMP Select the date of the first day of the last menstrual period LMP SonoScape 22 A6V A5V User Manual 3 8 Add Comments Annotations Office Select your office or department type here If OB is selected the estimated date of deliv
44. or color LCD Set Click the triangular bracket button or turn MENU to change the LCD brightness SysVersion Click this button to view the system information Beep Set Set it to ON to enable the beep sound effect DateFormat Set the date format for the clock displayed on screen OK Save changes and exit Cancel Exit without saving changes Load default Discard the current setting and load the default setting 3 6 2 Dicom Setting At the System Setting window click DICOM Setting to activate the DICOM Setting win dow Figure 3 5 Dicom Setting The items in DICOM Setting are explained below System Network SonoScape 18 A6V A5V User Manual 3 6 System Setting ezNetwork Check this option otherwise network support for the ultrasound system will be disabled Set DHCP Check this option to use the Dynamic Host Configuration Protocol DHCP to retrieve the configuration information from the server Set fix IP Manually set the network addresses If this option is checked you need to provide the local static IP address the NetMask and the Gateway addresses Server Network Export USB Check this option to enabling exporting data to USB Export Remote Check this option to enable DICOM data transfer through net work You need to enter the server IP address the server port number and the server name Save Save changes and exit Cancel Discard changes and exit 3 6 3 Formula Select Figure 3 6 Formula
45. r The immersion level should be kept below the junction line High level disinfection is recommended for surface probes and required for intracav itary probes Note that you may need to rotate and shake the transducer in order to remove the air bubbles between the transducer surface and the germicide solution After removing the probe from the germicide solution rinse it thoroughly with clean potable water to remove all visible germicide Dry the probe with a soft cloth lRefer to the germicide manufacturer s instruction to perform high level disinfection 60 SonoScape A6V A5V User Manual System Maintenance We recommend the user to perform the following maintenance operations e Clean the probes and probe holders daily to remove coupling gel dust and etc e Clean the system keyboard monitor and etc regularly A Attention Switch the system off before cleaning Damp cloth soaked in mild soap water is allowed Protect the system especially the electric parts from drip water Do not apply acetone alcohol or use abrasives on the system orthe trans ducer surfaces 7 1 Guidance for Service In case of any malfunctions turn off the system and disconnect the power supply Con tact your SonoScape representative for service Mention the detailed phenomena of the malfunction to the service personnel to help the identification of cause A Warning There are no user replaceable parts inside the system Any k
46. rizontal movement is possible and press SET 4 The measurement result will be displayed N Slope Description To measure the slope velocity of a line across two points Instructions 1 In M mode or B M mode press Calc highlight Slope and press SET 2 Move the cursor to the start point and press SET The slope measured from the cursor position to the start point is displayed on the screen 3 Move the cursor to the end point and press SET 4 The measurement result will be displayed Heart Rate Description To calculate the heart rate by placing two points SonoScape 48 A6V A5V User Manual 4 3 M Mode Measurements Instructions In M mode or B M mode press Calc highlight Heart Rate and press SET Move the cursor to the start point of the period and press SET The heart rate mea sured from the cursor position to the start point is displayed on the screen Move the cursor to the end point of the period and press SET The distance and the time duration between the two points and the heart rate will be displayed 4 3 2 M Mode Advanced Measurements Left Ventricular LV Function Assessment Refer to Table 4 1 Table 4 2 and Table 4 3 for the definitions of the measurement and cal culation items To assess the LV function in M mode three different formulae are possible Teichholz formula Cube formula and Gibson formula Left ventricular wall thickness of the inter ventricular septum
47. s It may interfere with or be interfered by other high frequency devices e g medical lasers Extra safety measures must be taken if other HF devices have to be used nearby While the system is designed to provide diagnostic information it is the operator s re sponsibility to ensure that this information is properly interpreted The manufacturer shall not assume any responsibility for the misinterpretation of ultrasound images We recommend back up any important data on the system to external media such as USB drive and CD DVD The manufacturer shall not be responsible for any data loss including but not limited to the patient data due to malfunction The installation shall be performed only by the personnel authorized by the manu facturer Do not attempt to install the system by yourself Repair service shall be performed only by the service technicians authorized by the manufacturer 1 SySTEM SAFETY e To avoid the danger of explosion never operate the system in the presence of flammable gases e Power off the system before cleaning Protect the system from water or other liquid drops e To ensure the safety of the patient prolonged continuous scan on the same part of the patient is prohibited e Apply the coupling gel which is bio compatible on the transducer surface or the pa tient skin before an ultrasound scan To ensure safety only the legal marketed cou pling gel complying with the relevant standards should be used
48. s XXX and YYY represent two different arbitrary numbers between 2 and 255 Accessing the system files from the PC Type the ultrasound system s IP address ftp 10 0 0 XXX into the address bar of the Internet Explorer and press Enter Data on the ultrasound system will be shown in the IE window You may copy or delete these files directly Figure 3 13 Connection and configuration for FTP access SonoScape A6V A5V User Manual 25 3 SYSTEM OPERATION 3 9 1 File Burning Figure 3 14 File burning window Click Burn at the Disk Management window to open the File Burn window The following operations are available Test Select the media type from the dropdown list click Test The CD DVD information including the available free space will be displayed gt gt Click gt to add the selected file to the burning buffer Click gt gt to add all the files and folders in the current directory to the burning buffer The total size of the files to be burned BurnSize should be no more than the free space available on the CD DVD lt lt Select a file in the burning buffer window click lt to remove the files from the buffer Click lt lt to clear all the files and folders from the buffer Burn Click it to start Burning files Data can be added to a single disc later if the BurnType is set to Increment 3 10 Bodymark Press BodyMark in an application mode to activate the BodyMark window SonoScape
49. s Provided as the user s request Protective earth wire 1 pc Fuse 1 6A 250V 2 pcs S VIDEO cable 1 pe BNC video cable 1 pc USB2 0 cable 1 pe VGA video cable 1 pe Coupling gel 1 bottle 2 4 2 Optional Accessories DVD writer Docking cart Backpack Foot switch Biopsy guide Additional transducers SonoScape 10 A6V A5V User Manual 2 4 System Configuration 2 4 3 Optional Peripherals USB2 0 disk drive USB2 0 removable hard disk drive USB2 0 CD DVD writer USB2 0 video printer Composite video printer Network printer VCR SonoScape A6V A5V User Manual 11 System Operation 3 1 Operation Notice A Warning 1 The system shall be operated by a trained sonographer 2 Before using this system please make sure that this manual has been read and properly understood 3 2 Transducer Connection The transducer ports are at the back of the system LOCK Instructions e Plug the probe into the probe socket ed e Turn the lock on the transducer clockwise to lock the transducer in position A Attention Either freeze the ultrasound image by pressing FREEZE or turn off the system before connecting or removing a transducer 3 3 Power ON OFF A Warning Review Chapter 1 and ensure it has been properly understood before you turn on your ultrasound system 13 3 SYSTEM OPERATION Before the system is powered on please make sure that 1 The power supply meets the req
50. s SET 2 Draw two line segments 3 The length of the two line segments and the angle between them will be displayed If necessary continue to measure another group of line segments 35 4 MEASUREMENTS Distance Angle Ratio Volume 0B Equine OB Feline OB Ovine OB Canine OB Bovine Prostate Vol Left Kidney Right Kidney RNA Repart B Plane Bullet Simpson L Follicle 2 Follicle 2 Follicle 3 R Follicle ruix Contrast Table Report Figure 4 1 B mode measurement and calculation menus part one SonoScape 36 A6V A5V User Manual 4 1 B Mode Basic Measurements S Plane B Plane Bullet Calc TIN LUANG LULd LUA Md LUAPd LUIDd LUAS UBS us LUANS Luas _ LUIDs Figure 4 2 B mode measurement and calculation menus part two Set confirm Traceball move Set confirm Figure 4 3 Distance Measurement 4 1 3 Ratio Description To calculate the ratio of two distances or areas Instructions to calculate the ratio of two distances 1 Press Calc highlight Ratio and press SET 2 Highlight Distance and press SET 3 Draw two line segments 4 The ratio i e the length of the first line segment divided by the length of the second line segment will be displayed If necessary continue to calculate another ratio Instructions to calculate the ratio of two areas Measure two areas the ratio will be the first area divided by the second area Refer to
51. s SET 3 Highlight Left Kidney for measuring the left kidney or highlight Right Kidney for measuring the right kidney then press SET Draw a line segment to measure Length Draw a line segment to measure Width Draw a line segment to measure Height 7 The measurement and calculation results will be displayed nu pb Urology Report Description To activate the Report window for writing urology report Refer to Section 3 12 4 2 5 Small Part Measurements Volume of Left and Right Thyroid Lobes SonoScape 46 A6V A5V User Manual 4 3 M Mode Measurements Description To measure the three axial distances D1 D2 D3 of the left or right thyroid gland and estimate the left or right thyroid volume Thyroid Volume 0 520 x Length x Width x Height Instructions 1 Scan the patient in the appropriate plane 2 Press Calc highlight Small Part and press SET 3 Highlight L Thyroid for measuring the left thyroid lobe or highlight R Thyroid for measuring the right thyroid lobe then press SET Draw a line segment to measure Length Draw a line segment to measure Width Draw a line segment to measure Height 7 The measurement and calculation results will be displayed ou Bs Volume of Parathyroid Gland Description To measure the three axial distances D1 D2 D3 of the parathyroid gland and estimate the volume Parathyroid Volume 0 520 x Length x Width x Height Instructions 1
52. s containing ethyl oxides on the probe 6 4 2 Cleaning Instructions 1 Disconnect the probe from the ultrasound system Remove the biopsy guide if it is attached to the probe Remove all the coupling gel and clean the probe with soft cloth and flowing potable water If the probe surface carries too much residue remove all visible residue with wet cloth soaked in mild soap water Use wet soft cloth to scrub the surface if dried residue exists Remove all soap water residue with damp cloth soaked in potable water Air dry or dry with a soft cloth 6 4 3 Disinfection Instructions The level of disinfection is directly related to the duration of contact with the germicide High level of disinfection is recommended for surface probes and required for intracavitary probes Legally marketed liquid chemical germicides e g Cidex are highly recommended Prepare and use the germicides following the manufacturer s instructions A Warning e DO NOT use high pressure steam to disinfect the probe e DO NOT use thermal disinfection Temperatures higher than 66 C or 150 F will damage the probe Ensure that all visible residues have been removed Prepare the germicide solutions according to the manufacturer s instructions Please also follow the manufacturer s instructions for storage and disposal of the germicide Immerse the probe head into the germicide for a time interval specified by the ger micide manufacture
53. t e Check the expiration date of the probe sheath and the coupling gel Never use expired probe sheath and coupling gel e Latex or natural rubber contained inside medical equipments or accessories can cause severe allergic reactions in some individuals It s suggested by FDA that the user should identify the latex sensitive patients and be prepared to treat allergic reactions promptly e Only water soluble coupling gel should be applied to the probe head surface Avoid contact with the mineral oil For Surface Probes Put an adequate amount of coupling gel either on the probe head acoustic window or the patient skin If disease transmission is a concern use of the sterile probe sheath is highly recommended Refer to instructions below to use the probe sheath as a barrier between the patient and the transducer surface For intracavitary probes Note The probes are provided in non sterile condition from the manufacturer SonoScape 58 A6V A5V User Manual 6 4 Probe Maintenance Cleaning and Disinfection Intracavitary probes should be cleaned and disin fected both before and after usage 1 To prevent disease transmission wear sterile gloves 2 Put an adequate amount of coupling gel on the probe head or into the probe sheath 3 Insert the transducer into the probe sheath quired for intracavitary operations If lubricant is used it must be water soluble Do not apply cou pling gel directly on the pat
54. ted by following these rules e Freeze the system or keep the probe away from the patient if no scanning is per formed e Do not scan the patient at a fixed position of the body for a prolonged time This product should be used only for valid reasons and should be used both for the shortest period of time and at the lowest power settings necessary ALARA As Low As Reasonably Achievable to produce diagnostically acceptable images The AIUM also offers the following guidelines Clinical Safety Quoted from ATUM Approved March 26 1997 Diagnostic ultrasound has been in use since the late 1950s Given its known benefits and recognized efficacy for medical diagnosis including use during human pregnancy the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use There are no confirmed biological effects on patients or instrument operators caused by exposures from present diagnostic ultrasound instruments Although the possibility exists that such biological effects may be identified in the future current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks if any that may be present SonoScape A6V A5V User Manual 3 1 SYSTEM SAFETY For more detailed discussion about safety of diagnostic ultrasound refer to Medical Ultra sound Safety AIUM 1994 1 4 1 5 1 6 1 7 Requirements for Operation Environmental requirements
55. the length of the major axis B is the length of the minor axis V xAxB Instructions 1 Press Calc highlight Volume and press SET 2 Highlight 2 Axis and press SET 3 These two steps draws an ellipse Draw a line segment representing the major axis of the ellipse 4 Draw another line segment representing the minor axis of the ellipse 5 The volume will be displayed If necessary continue to measure another volume 3 Axis Description To measure a globe like volume using three distances The following for mula is used to calculate the volume D Da and Ds are the length of three mutually perpendicular axes V x Di x Da x Ds Instructions 1 Press Calc highlight Volume and press SET SonoScape 38 A6V A5V User Manual 4 2 BMode Advanced Measurements Figure 4 4 A ovoid with its three axis displayed 2 Highlight 3 Axis and press SET 3 Draw three line segments which represent the three axes of the ovoid 4 The volume will be displayed If necessary continue to measure another volume 4 2 B Mode Advanced Measurements The B mode advanced measurements include OB measurements Gynecology measurements Cardiology measurements Urology measurements Small parts measurements 4 2 1 OB Measurements Gestational Sac GS measurement Description To measure the Gestational Sac and calculate the Gestational Age GA Instructions 1 Press Calc highlight OB Equine for equine or OB Canine
56. to Section 4 1 4 for instructions Measure LVAMS refer to Section 4 1 4 for instructions 10 Measure LVIDs refer to Section 4 1 1 for instructions 11 The measurement and calculation results will be displayed O ON DU SH Bullet Items to be measured LVAMd LVLd LVAMs LVLs Items to be calculated EDV ESV SV CO EF SI CI Formula EDV x LVLd x LVAMd ESV x LVLs x LVAMs Measurement instructions 1 Scan the patient in the appropriate plane 2 Press Calc highlight Cardiac and press SET 3 Highlight LV and press SET to open the submenu highlight Bullet in the submenu and press SET Measure LVAMd refer to Section 4 1 4 for instructions Measure LVLd refer to Section 4 1 1 for instructions Re scan the patient in the appropriate plane Measure LVAMS refer to Section 4 1 4 for instructions Measure LVLs refer to Section 4 1 1 for instructions 9 The measurement and calculation results will be displayed ON AOS Simpson Items to be measured LVAMd LVLd LVAPd LVAMs LVLs LVAPs Items to be calculated EDV ESV SV CO EF SI CI Formula LVL EDV Wid x 4 x LVAMd x 2 x LVAPd VLVAMd x LVAPd ESV gt x LVLs x LVAMs SonoScape 44 A6V A5V User Manual 4 2 BMode Advanced Measurements Measurement instructions 1 Scan the patient in the appropriate plane 2 Press Calc highlight Cardiac and press SET 3 Highlight LV and press SET to open the submen
57. u highlight Bullet in the submenu and press SET Measure LVAMd refer to Section 4 1 4 for instructions Measure LVLd refer to Section 4 1 1 for instructions Re scan the patient in the appropriate plane Measure LVAMS refer to Section 4 1 4 for instructions Measure LVLs refer to Section 4 1 1 for instructions 9 The measurement and calculation results will be displayed ON MN Uma Right Ventricular RV Internal Diameter Description To measure the internal diameter of right ventricule Instructions 1 Press Calc highlight Cardiac and press SET 2 Highlight RV and press SET 3 Draw a line segment to measure the internal diameter of the RV 4 The measurement result will be displayed Internal Diameter of Pulmonary Artery PA Description To measure the internal diameter of pulmonary artery Instructions 1 Press Calc highlight Cardiac and press SET 2 Highlight PA and press SET 3 Draw a line segment to measure the internal diameter of the PA 4 The measurement result will be displayed Cardiology Report Description To activate the Report window for writing cardiology report Refer to Sec tion 3 12 4 2 4 Urology Measurements Residual Urine Volume RUV Description To measure the three axial distances Length Width Height of the bladder and estimate the bladder volume Bladder Volume 0 7 x Length x Width x Height Instructions 1 Scan the patient in the appropr
58. uirements for proper operation of this system 2 The system is effectively grounded by grounding the protective earth pin using the protective earth wire provided with the system 3 The power switch on the rear panel is set to OFF Power supply connection Connect the system to the power supply with the power cable supplied with the system Turn on the system When the power supply is connected press the power switch on the rear panel to turn on the system Once the system is turned on the keyboard will be illuminated and the splash screen with the logo will appear The initialization takes about 1 minute to complete before the EXAM interface appears Turn off the system Switch the power switch on the rear panel to OFF and the system will be turned off im mediately Note After powering off the system wait for a least 5 seconds before restart ing In case that the system is restarted too often the power supply s self protection mechanism will be activated to protect the system 3 4 Keyboard Functions This ultrasound system uses backlight control panel the layout of the keys has been opti mized such that complicated operations can be easily accomplished The control panel shown in Figure 3 1 includes the alphanumeric keyboard 6 control keys and 23 function keys 3 knobs FUNC MENU GAIN and 8 TGC slider controls Item Key Description 1 Exam Return the system to the preparation mode EXAM scr
59. w to use the zoom function Activate the zoom func tion Zoom factor Zoom area Zoom in Readjust Turn off zoom function Figure 3 20 Zoom Press FUNC several times until the Zoom function is active A box Figure 3 20 appears on the ultrasound image Turn FUNC to change the magnification factor Move the trackball to change the zoom area Press SET to zoom in the area enclosed by the zoom box When the image is magnified move the trackball to move the zoom box turn FUNC to change the magnification factor Press FUNC to turn off the zoom function SonoScape A6V A5V User Manual 33 Measurements B mode measurement and calculation menus are shown in Figure 4 1 and Figure 4 1 4 1 B Mode Basic Measurements The basic measurements in B mode includes e Distance e Angle e Ratio e Area and circumference e Volume 4 1 1 Distance Description To measure the length of a line segment Instructions 1 In B mode press Distance 2 Draw a line segment Use the trackball to move the cursor to the start point of the measurement and press SET to fix the marker Move the cursor to the end point of the measurement and press SET 3 The result of the distance measurement will be displayed If necessary continue to measure another distance in the same manner 4 1 2 Angle Description To measure the angle between two line segments 0 to 180 Instructions 1 Press Calc highlight Angle and pres
60. y LD Region REGION Dynamic Range DYN Persistence PER Edge Enhancement ENH Rotation ROT GSC BGSC Chroma BMAP Analog Gain A GAIN Biopsy Position Angle The line density of the ultrasound image This item controls the scan angle for convex array transducers or the sector width for linear array transducers The dynamic range value The B mode persistence value Edge enhancement number Rotate the active ultrasound image Grayscale curve The color coding method for ultrasound images The analog gain of the image Options for biopsy setup Refer to Section 3 11 The following M mode imaging parameters are possible Power PWR Frequency FREQ M Persistence MPER Smooth MSMO M Enhancement MENH GSC Dynamic Range DYN The acoustic output power keep it as small as possible The ultrasound frequency generated by the transducer The M mode persistence value Smoothen the M mode display M mode edge enhancement number Grayscale curve The dynamic range value 32 SonoScape A6V A5V User Manual 3 14 Imaging Region REGION Sweep speed MSP SLOPE 3 14 3 Zoom This item controls the scan angle for convex array transducers or the sector width for linear array transducers The speed at which the M curve refreshes Slope In the single B mode with the default orientation i e without rotation or flip the image can be zoomed Follow instructions belo
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