USB ULTRASOUND PROBE SYSTEM USER MANUAL
Contents
1. Figure 12 7 9 2 Adjusting the Intensity The intensity control adjusts the overall intensity or brightness of the image To darken the image move the intensity slider up and to lighten the image move it down As with the Gain controls adjusting intensity while scanning or frozen or on a previously saved image is allowed 7 9 3 Adjusting the Contrast Dynamic Range The contrast control adjusts the overall contrast of the image Slide this control up and down to increase and decrease the amount of contrast between light and dark areas of the image As with the Gain controls adjusting contrast while scanning or frozen or on a previously saved image is allowed 8 Documentation Printing an image The current image is printed to any available Windows supported printers The current patient data is printed with the current time and date Any setting currently in effect will be preserved in this printed image Saving an image Saves the currently displayed image data set USB Images data to a file The raw data is saved so that it can be retrieved and processed as if it were captured live Saving a cine Stored image buffers that record a history of a scanning session The more buffers the longer the history that may be saved and played back Page 18 of 38 8000CE INS UMENG Rev 0 9 Set up and Customizing Custom settings save the current Image Control settings to a named setting for future recall and use Figure2. NA N Output power mW c 0 173 0 173 Bounded output power 0 056 N S E Attenuated spatial peak 0 41 temporal average intensity mW cm2 Peak rarefactional 14 acoustic pressure MPa Attenuated peak 0 6 rarefactional acoustic pressure MPa 1 2 dB output beam 0 28 area cm2 Equivalent aperture diameter cm Depth at max 1 57 1 57 NA attenuated pulse intensity integral cm Supplementary information Z Z Z Z Z Z Z gt gt gt gt gt gt B Mode only with 60 degree scan angle 15 Hz scan rate and 256 lines per scan Page 35 of 38 8000CE INS UMENG Rev 0 APPENDIX E USB probes indications for use N I I z Te ite M a oc o 7 Clinical Application A B Opthalmic Fetal Abdominal Intra Operative Specify Intra Operative Neurological Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Trans Rectal Trans Vaginal Trans Urethral Intra Vascular Peripheral Vascular Laparascopic Muscular Skeletal Conventional Muscular Skeletal Superficial Others Specify A A Scan B B SCAN Page 36 of 38 gt SP 7 5 MHz x lt X lt X lt x lt U gt ER 7 5 MHz x lt Xx x lt U gt MV 12 MHz X x lt U gt EC7 5 MHz Xx U 8000CE INS UMENG Rev 0 APPENDIX E Continued USB probes indications f
3. Custom Settings DEFAULT E ES Image Controls Far Mid Near Inten Cont Gain Gain Gain i Probe Controls 0 GP 5 MHz Pulse so MHz v Freq Depth 15 cm nl Pulse Power Low Processing Controls Caliper CA CB Frame 31 13 16 fps x 60 y 3 3 93 104 72 mm A 0 00mm_ B 0 00 mm 15cm 3 5 MHz GP 5 MHz Figure 1 7 5 2 Commands Manual e Top of display window will show the current software version File This section has option for dealing with various files Open Will open USB Images files that were previously saves Save As Will save the USB Images data for later viewing Load Cine Buffer Allows loading a previously saved cine file for playback and analysis Save Cine Buffer Allows saving the current cine file to disk Print Will print the current image display to a printer Exit Will shut down the scanner and exit the application Page 8 of 38 8000CE INS UMENG Rev 0 Edit The Edit Manual supports copying the current image data to the Windows clipboard This is useful for pasting data into text documents or saving into an image format The exact display is saved including LUT TGC Zoom parameters Settings This selection brings up the dialog box Figure 2 to creating and saving the Presets Patient V Require Patient Name v Automatically Create Patient Directories v Automatically Generate File Name V Automatically Save File on Freeze V Automatically Save on Button Press F
4. condensing Storage Temperature 10 C to 50C 14 F to 122 F Probe Dependent Page 25 of 38 8000CE INS UMENG Rev 0 APPENDIX B Computer System Specifications Open System Architecture System Specification Requirements for PC or Laptop Celeron or Intel processor 1GHZ MHz or higher 512 MB or greater Mouse Touchpad LaserMouse orUSB Mouse or equivalent AC Adapter Medical Medical Grade SS Battery Type e n a asas or equivalent Operating System Windows XP Home Professional editions or Windows Vista Software nterson Corporation USB Ultrasound version 3 62 or Higher Warranty BE ERI 1 year for Ultrasound probe Special Options N WARNING The use of a Non Medical grade AC Adapter could potentially cause harm to the system the probe the operator and or the patient Page 26 of 38 8000CE INS UMENG Rev 0 APPENDIX C USB probes and their applications Description Product Design Product Targeted Use USB PROBE MV 12 0 MHZ Human Vascular Phlebotony Focal Point 0 5cm Max depth 2 0cm Patient contact area 25mm Displayed depth 3cm USB PROBE SP 7 5 MHZ Human Superfical Anatomy Focal Point 2 0cm Max depth 10 0cm Patient contact area 20mm Displayed depth 5cm 10cm USB PROBE EC 7 5 MHZ Human endo cavity trans vagnial OB GYN Focal Point 2 5cm Max depth 10 cm Patient
5. on the Scan icon again will stop the scan If scanning is in process the icons buttons are grayed out and not available for use with the exception of Full View which is used to return a magnified view of the scan image to its normal size The scan control button on each probe can control starting and stopping a scan The Scan icon and or the scan control button on the probe are completely interchangeable Starting a scan with the Scan icon and stopping with the scan control button on the probe is possible Page 12 of 38 8000CE INS UMENG Rev 0 Exam Data Exam Data is the patient name and an open text field for comments If the Preference setting requiring a Patient Name has been selected and a scan initiated an error message will be displayed indicating that a Patient name is required before the scan can begin The Patient Name data is saved with image and cine files and will be displayed at the top of the imaging window The comments in the text field is printed when the images are printed Help User guides references manuals and other resources that provide information about using the USB Probe system are available through the Help button in the top right corner panel of the Main Menu 7 5 4 Status Bar The status bar at the bottom of the ISSUSB window displays information about the status of the session results from measuring commands and other types of information that may be useful during a scanning session F
6. 4 3 Expose all parts of EUT to field Immunity 3V m 80 1kHz EFT EN60601 1 2 2Kv 36 202 1 j EN61000 4 4 None I O Only 5 50 5kHz Conducted EN60601 1 2 0 15 80MHz 36 202 1 j EN61000 4 6 None Immunity 3Vrms I O Only 80 1KHz Guidance and Manufacturer s Declaration Electromagnetic Immunity DGH Technology s USB Ultrasound Probes are intended for use in the electro magnetic environment specified below The customer or the user of the DGH Technology USB Ultrasound Probe should ensure that it is used in such an environment Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios armature radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the DGH Technology USB Ultrasound Probe is used exceeds the applicable RF compliance level the DGH Technology USB Ultrasound Probe should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the DGH Technology USB Ultrasound Probe system 11 Storage and Transportation 1 When the Probe is not being used it should be stored clean dry area IN CAUTION Do not stor
7. Aaprt gt 1 cm 23 5 19 8 ion Z Z Z Z Z Z Z Z Z gt gt gt gt S gt gt B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan Page 33 of 38 8000CE INS UMENG Rev 0 MV 12 0 MHz Probe TABLE Summary of the acoustic quantities MV 12 0 MHz Probe Im p p w Output power mW 0 72 Bounded output power 0 27 J Acoustic working frequency MHz 0 72 0 27 gt Attenuated output power mW g z w ON on Jm ER o Spatial peak temporal average intensity mW cm2 Attenuated spatial peak 34 temporal average i intensity mW cm2 Peak rarefactional acoustic pressure MPa Attenuated peak rarefactional acoustic pressure MPa 1 2 dB output beam area cm2 0 38 Equivalent aperture 0 70 diameter cm Depth at max 0 10 0 10 NA attenuated pulse intensity integral cm Supplementary information 0 70 Z Z Z Z Z Z Z Z Z gt gt gt gt S gt gt B Mode only with 60 degree scan angle 15 Hz scan rate and 256 lines per scan Page 34 of 38 8000CE INS UMENG Rev 0 OP 12 0 MHz Probe TABLE Summary of the acoustic quantities OP 12 0 MHz Probe Scanning Non scanning Non scanning Scanning Non scanning Acoustic working 10 4 10 4 frequency MHz 173 0 173 173 0 173 Attenuated output 0 056 0 056 power mW Spatial peak temporal 1 26 average intensity mW cm2 J 10 4 N gt
8. Scanning Non scanning Non scanning Scanning Non scanning Aap 1 cm Aaprt gt 1 cm J Acoustic working frequency MHz Output power mW 38 2 38 2 gt Bounded output power Attenuated output power mW 14 1 8 E Spatial peak temporal average intensity mW cm2 Attenuated spatial peak temporal average intensity mW cm2 Peak rarefactional acoustic pressure MPa Attenuated peak rarefactional acoustic pressure MPa 1 2 dB output beam area cm2 Equivalent aperture diameter cm2 Depth for TIS EEES Depth at max 3 93 3 93 NA attenuated pulse i intensity integral Supplementary information W Z Z Z Z Z Z Z Z gt gt gt gt gt gt gt gt Z Z Z Z Z Z Z Z Z Z Z Z Z gt gt gt gt gt gt gt gt gt gt gt gt gt B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan Page 30 of 38 8000CE INS UMENG Rev 0 SP 7 5 MHz Probe S Scanning Non scanning Non scanning Scanning Non scanning Aaprt 1 en Aaprt gt 1 cm 16 5 11 4 10 6 Spatial peak temporal average intensity mW cm2 Attenuated spatial peak temporal average intensity mW cm2 Peak rarefactional acoustic pressure MPa Attenuated peak rarefactional acoustic pressure MPa 1 2 dB output beam area cm2 Equivalent aperture diameter cm Depth at max 1 33 1 33 NA attenuated pulse
9. contact area 21mm Displayed depth 5cm 10cm USB PROBE SR 7 5 MHZ i y x y Human Superfical Anatomy Focal Point 2 0cm Max depth 10 0cm Patient contact area 20mm Displayed depth 3cm 5cm 6cm 10cm USB PROBE ER 7 5 MHZ EE i Human endo cavity trans rectal Focal Point 2 5cm Max depth 10 cm Patient contact area 64mm Displayed depth 5cm 10cm USB PROBE OP 12 MHZ o a Human Ophthalmology Posterior eye anatomy Focal Point 1 7cm Max depth 6cm Patient contact area 16mm Displayed depth 3cm 5cm 6cm 10cm Page 27 of 38 8000CE INS UMENG Rev 0 USB PROBE GV 5 0 MHZ VET Veterinary Abdominal medium large dogs large cat Focal Point 3cm Max depth 15cm Patient contact area 21mm Displayed depth 10cm 15cm USB PROBE SV 7 5 MHZ Veterinary Abdominal Thoracic small dogs cats Focal Point 2cm Max depth 10cm Patient contact area 13mm Displayed depth 5cm 10cm USB PROBE GS 5 0 MHZ LONG VET S li Veterinary trans rectal Bovine Reporduction Focal Point 6cm Max depth 20cm Patient contact area 21mm Displayed depth 5cm 10cm USB PROBE GS 7 5 MHZ LONG VET Veterinary trans rectal Bovine Reproduction Focal Point 2 5mm Max depth 10cm Patient contact area 21mm Dis
10. corner of screen Image The Image menu has options for changing how the imaging will be performed or how the current image will be displayed Average Will turn on frame to frame averaging This is the default setting If the processor in the host computer cannot display images at the frame rate desired turn off averaging This will improve display performance at the expense of image quality Interpolate Will turn on off the linear interpolation of the image Zoom Mode Will turn off the zoom mode if the image window is currently zoomed This resets the image display to the defaults for that probe type Grid Turns on off grid makers on image window Several preset grid spacing options are available The Grids will scale when zooming on an area of the image Bidirectional Scan Turns on off bidirectional scanning The effective frame rate will drop by one half if bidirectional scanning is turned off By default it is turned on Goggles Turns goggles on or off if this option installed Cine The Cine menu allows customization of how the cine buffers are used Frames after Trigger Selects how many cine frames to be captured after pressing the stop button up to the number of buffers in the cine memory The default is zero 0 The scanner will stop acquiring data when the button is pressed Cine Buffers The Cine Buffer is a continuously recording loop of the scan The length of the loop is determined by selecting of the num
11. devices To ensure electromagnetic compatibility EMC DGH Technology USB Ultrasound Probes must be installed and operated according to the EMC information provided in this manual The DGH Technology USB Ultrasound Probes have been designed and tested to comply with IEC 60601 1 2 2002 requirements for EMC with other devices ZN CAUTION Portable and mobile RF communications equipment may affect the normal function of the DGH Technology USB Ultrasound Probes ZN CAUTION Do not use cables or accessories other than those provided with the DGH Technology USB Ultrasound Probe as they may result in increased electromagnetic emissions or decrease immunity to such emissions Page 20 of 38 8000CE INS UMENG Rev 0 Guidance and Manufacturer s Declaration Electromagnetic Emissions amp Immunity DGH Tec hnology USB Ultrasound Probes are intended for use in the electromagnetic environment specified below The customer or the user of the USB Ultrasound Probe should ensure that it is used in such an environment Environmental Test In Level Criteria Basic Notes Phenomena Accordance to Standard Radiated EN60601 1 2 Group 1 Under CISPR 11 Measure at 5 meters Emissions Class a Limit Electrostatic EN60601 1 2 2Kv 4Kv 8Kv_ 36 202 1 j EN61000 4 2 Apply to all accessible components Discharge contact discharge 2Kv 4Kv 8Kv air discharge Radiated EN60601 1 2 80MHz 2 5GHz 36 202 1 j EN61000
12. edad dq edd 18 7 9 3 Adjusting the Contrast Dynamic Range eere 18 8 DOCUMENTATION getty repo ana Meets Mes eee adobe ne es a eet 18 9 SET UPAND CUSTOMIZING ttt eee Yee eee ee E Eee e EE e Ee Tyre ava ee geo o Eee essa dan 19 10 ELECTROMAGNETIC COMPATIBILITY essere enne enhn enne ennt enne 20 11 STORAGE AND TRANSPORTATION 00 ccccecccccessseceseceeseceeaeeceeeeecseeseaaeceeaeeceseeeeaeceeaeeseeeees 21 12 TRANSPORTATION eter A ARA ioo de ride ck etd idet er Dee sh ee E LH RE EORR 22 IX CARE OFTHE USB PROBE eene teneret etg ete ee tede eee Ais 22 14 BIRI HON REUS 23 15 TROUBEESHOOTINQ iieri HE nite les des ead E DRE Ree eta ee Hia eaae GL eee ed Toad 23 16 CUSTOMER SERVICE eec eot couse ex Ere vedere Fee dee TE E esee etre taque 23 IT GEOSSARY OE TERM eere ee rette eme eer tena erre te tee eig eee Ee Eee en dee EEEa aT 24 15 SPECIBICAPEIC NS eret etie repe tte te DRE RO PATI E n rU QU REC AREA E ERU RENE PER EINER 24 APPENDIX A 25 ie rtr te rt o ER e E B Ui e ere a bt EN E eO E 25 APPENDIX Bis 9 3 5 1 noise olei reete e es ete loe Oe Eee ed pede oe ced e eee TERT 26 jugaba H 27 APPENDIX D neto rae er a UR Dee AR PORE eR Oo REO OR a RAE ed ots en 29 APPENDIX Bre eiecti ten e t tf seid t e e ev RA He E dese 36 Page 2 of 38 8000CE INS UMENG Rev 0 1 Warnings and Cautions 1 4 Meaning of Signal Words In this users manua
13. operates over a 20 mm area as an end firing probe This device is intended for use with the USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of neonatal abdominal organs and structures including the gastrointestinal tract kidney bladder etc peripheral vessels and as an small organs aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 4 USB Transducer SF 7 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 7 5 MHz In B mode the transducer operates over a 64 mm area as a side firing probe This device is intended for use with the USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of endocavity etc and as a small organs aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria Page 37 of 38 8000CE INS UMENG Rev 0 5 USB Transducer MV 12 0 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 12 MHz In B mode the transducer operates over a 29 mm area as an end firing probe This device is intended for use with the USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of peripheral vessels and as a small organs aid in the detection and assessment of p
14. top Near Mid Far Inten Cont maximum setting at bottom Gain Gain Gain Probe Controls 0 Gv 5 MHz E Pulse S 0MHz2 Freq Depth 15 cm X Figure 9 Page 16 of 38 8000CE INS UMENG Rev 0 Custom Settings DEFAULT M El Be Image Controls Near Mid Far Inten Cont Gain Gain Gain Ee BE IEEE Probe Controls Improved imaging as a result of optimizing Image Controls 0 Gv 5 MHz Ed Pulse 5 0MHz v Freq Depth 15 cm v Figure 10 7 9 1 Adjusting the Gain The three gain controls in the right side of the Window menu allow adjustment for more or less gain in the far field Far Gain mid field Mid Gain or near field Near Gain To add more gain move the appropriate slider down Figure 12 To reduce the gain move the slider up Figure 11 The data stored by InterSonoScan is raw image data which can be retrieved Images or Cine data and adjusted There are two accelerator keys that can be used with the gain Ctrl R Will reset the gain to the default setting that was in effect when the program started Citrl Z Will set the gain to zero Image Controls Near Mid Far Inten Cont Gain Gain Gain y e m m m 5 minimum Gain Intensity and Contrast settings Figure 11 Page 17 of 38 8000CE INS UMENG Rev 0 Image Controls Near Mid Far Inten Cont Gain Gain Gain maximum Gain Intensity and Contrast settings I T I 1 eens Seagal l y I I
15. 13 Many configurable aspect of the program will be saved and recalled with that setting For example the current gain intensity and contrast settings will be saved So will the selected pulse and depth mode selections The size of the cine buffer grids and type of scanning averaging bidirectional will also be saved This allows quick recall preferred setups using this control Custom Settings perar s Figure 13 The current active setting is displayed in the pull down menu To change to another saved setting simply select it from the pull down menu To save the current settings to the active setting simply press the save settings icon to the right of the pull down menu This will overwrite the saved settings with the currently active settings To create a new setting name for the currently active settings delete a setting or save to a different setting name click the configure settings icon at the far right This will bring up the Custom Setting dialog box Figure 14 Custom Settings Ej m DEFALILT m New Done Figure 14 The current active setting name will appear in the pull down menu Another setting can be selected in this pull down menu and then save the current setting to it or delete the shown setting with the save and delete buttons respectively Deleting a setting is not reversible Take care when delete a setting as there will be no way to retrieve those settings To create a new setting click the New b
16. Rev 0 7 7 Selecting Cine Cine Buffer The Cine Buffer is a continuously recording loop of the scan The length of the loop is determined by selecting the number of frames to capture The larger the number of frames the more system memory is required The default is 32 frames Each frame is 512 KB To change the Cine Buffer move the cursor to Cine in the tool menu in the upper left hand corner Click on Cine and move the cursor to Cine Buffer The dialog box will appear Select Cine frames from 32 64 128 256 See Help menu for more detail 7 8 Setting up a new patient Exam Data is patient name and an open text field for comments If in the Preference a Patient Name is required and a scan is initiated an error message indicating that a Patient name is required before the scan can begin The Patient Name data is saved with image and cine files and will be displayed at the top of the imaging window The comments in the text field are printed when the images are printed 7 9 Working with the Image Controls While scanning a patient and adjusting the Image Controls on the right of the screen to optimize the image changing contrast brightness and gains the raw data is being acquired and saved by the transducer The image is then enhanced to the user s diagnostic requirement based on the Image Control settings Figure 9 amp Figure 10 Custom Settings peau Bill Bb Imaging Controls Image Controls minimal settings at
17. USB ULTRASOUND PROBE SYSTEM USER MANUAL SCANNIATE DGH 8000CE Equipment Manufacturer EMERGO EUROPE DGH Technology Inc Molenstraat 15 110 Summit Drive Suite B EC 2513 BH The Hague Exton PA 19341 USA The Netherlands Phone 610 594 9100 Phone 431 70 345 8570 Fax 610 594 0390 Fax 431 70 346 7299 C 0120 This user guide is applicable to but not limited to the following probes 3 5 MHz General Purpose GP 5 0 MHz General Purpose GP 5 0 MHz General Purpose GS 5 0 MHz General Purpose Veterinary GV 7 5 MHz Small Parts SP 7 5 MHz Endocavity EC 7 5 MHz Vascular SR 7 5 MHz Endo rectal ER 7 5 MHz Small Parts Veterinary SV 7 5 MHz General Purpose GS 12 0 MHz Micro Vascular MV 12 0 MHz Ophthalmic OP Information in this document is subject to change without notice Page 1 of 38 8000CE INS UMENG Rev 0 TABLE OF CONTENTS 1 WARNINGS AND CAUTIGONS 2 Erro HH ERR HH PEG HR RREME CURE HE nee LUE EERE 3 I L Meaning or Signal WOFPdS stets vette but teu tese eeto i ea aaa aei fedet 3 1 2 Nieamng of Satety Symb lras i eS e Eod E E E EAE E E E fue 3 1 3 General Cautions and WarHITISS eos re SURE DISNUD Lo et od EE inta taies eb ee ad eee s 3 14 Operator quali TTC ANIONS was e ot can eR PROV EXMA T UIS ROI Den et aves nc ioca een DUE E D PU T USES 4 2 CLEANING AND DISINFECTION ir ccccesssecssececeseeeesaeceeaeecneneeeaeceeaaecseaaecseceesaeceeaaecneneeenas 4 A PROG C le qnibos UR delectu
18. assed EN 60601 1 2 2007 standard 5 Prescription Device Statement CAUTION US Federal law restricts this device to sale by or on the order of a physician A N WARNING The sheath may contain natural rubber and talc which may cause allergic reactions For more information see the FDA s March 29 1991 Medical Alert on latex products 6 Training This USB probe system is intended to be used by trained medical professionals only The specific probe functions are described in this manual and are also available through the system software help menu 7 General This user guide is for the USB probe system Prior to using the probe become familiar with the operating instruction in this guide The USB probe system is a unique concept where the Ultrasound system is built entirely into the probe This USB probe system allows the user to image in real time and review cine or freeze frame images on the screen in B Mode scan format Page 6 of 38 8000CE INS UMENG Rev 0 7 1 Getting start Computer System Requirements minimum e Computer Operating System Microsoft Window XP Processor Pentium 1GHz MHz or better Memory Minimum of 512k RAM with 128k cache Display VGA graphics or higher 1024 by 768 NVIDA recommended Interface USB 2 0 port 7 2 Install software Software will not load if the Color Resolution is less than 24 bit Insert the USB memory stick into USB port or CD into the CD ROM of a laptop or
19. ber of frames to capture The larger the number of frames the more system memory that is required The default is 32 frames Each frame is 512 KB Page 10 of 38 8000CE INS UMENG Rev 0 Help Brings up a complete user help guide for questions that may arise during the operation and usage of the system 7 5 3 Button Bar The button bar Figure 3 beneath the main menu allows quick access to many often used functions Most of these buttons are disabled when scanning InterSonoScan tm 1 57 5 26 dee 01 amp 7 Ns 9 Open Save Open Cine Save Cine Copy Print Full View Scan Exam Data Help Figure 3 Open Open a saved image data set USB Images file The image in the window will be replaced by the retrieved data If the Exam Data has been entered for the current patient the Open selection will open that patient s ultrasound image folder that contains the patients still images if that patient had a previous ultrasound scan If the automatic save and filename was selected in the preference all of the image controls for gain and intensity can be used to adjust the saved image Zooming on areas of interest is allowed Save Saves the currently displayed image data set USB Images data to a file If preferences are configured to automatically save images this manual save function is useful when selecting individual images from a Cine Loop The automatic save preference enables the system to automatically create a filename If
20. de the service partner with the information listed in Prepare to call customer service Page 23 of 38 8000CE INS UMENG Rev 0 17 Glossary of Term USB Images The raw unprocessed data obtained from the scanner Cine Shorthand for Cine Buffers Cine Buffers Stored image buffers that record a history of a scanning session The more buffers the longer the history that may be saved and played back FPS Frames per Second GP General Purpose ISSUSB Interson USB Software application that allows imaging with DGH Technology Inc Ultrasound Probes JPEG Joint Photographic Experts Group Commonly used to refer to an image file format defined by this group KB Kilobytes 2 10 1024 bytes MB Megabytes 2 20 1048576 bytes OP Ophthalmic Pixel Picture Element the smallest unit of display on a monitor USB Universal Serial Bus A standard for connecting peripherals to computers 18 Specifications Imaging Modes B and FREEZE mode Imaging resolution 2 mm focal point for 3 5 MHz probe Grey Shades True 256 8 bits Scanning Method 90 degree sector Probes Signal element probe 3 5 MHz 5 0 MHz 7 5 MHz 12 MH Multi frequency probes Depth Selection 5 cm 10 cm 15 cm 20 cm Measurements Mouse Trackball operations Point move and measure Signal processing Fully digital User PC monitor and keyboard TGC LUT Control Acoustic power control Frame averaging Brightness and contract Interpola
21. desktop computer Install software from the root directory on the USB memory stick or CD A Welcome screen appears Move cursor to select Next gt 2 3 4 5 The Installation Options screen appears 6 Follow the onscreen prompts It is recommended to install in a new directory 7 The Ready to install screen appears 8 Move cursor to select Install 9 A Completing the InterSonoScan USB Setup Wizard Screen appears 10 Click on Finish 11 Click on Finalize and Close 12 Any changes made to the installation procedures after this manual is printed can be obtained from DGH Technology 7 3 Update software 1 Any updated software will be noted by DGH Technology or local DGH Technology Distributors 7 4 USB Probe Installation 1 Connect the USB probe system to one of the USB2 ports 2 Windows XP will display FOUND NEW HARDWARE message when the probe is inserted This process will occur twice because of the hardware being installed requires that Windows XP finds two USB2 devices within our product and is normal operation Once this installation process has finished twice the system is ready to use Page 7 of 38 8000CE INS UMENG Rev 0 7 5 The USB Ultrasound Probe Interface 7 5 1 Main Window e USB Probe s main window comprises the commands shown in Figure 1 InterSonoScan c 1 96 6 41 i e 3 7 NN s Open Save Open Cine Save Cine Copy Print Full View Scan Exam Data Q Cine Frame NS DN GR DUE n
22. e the probe in the shipping case It may become a source of infection 2 Page 21 To prevent damage to the probe do not store in areas where it might be exposed to e Excessive vibration e Excessive dust amp dirt of 38 8000CE INS UMENG Rev 0 3 Store the probe under the following ambient conditions e Temperature 10 C to 50C 14 F to 122 F e Relative Humidity 20 to 80 no condensation e Atmospheric pressure 700 hPa to 1060 hPa 12 Transportation 1 Never carry the probe by the cable The cable could disconnect from the probe allowing it to drop and possibly damaging the probe 2 Never bend the USB cable in a tight radius This could result in damage to the cable 3 Transport the probe under the following ambient conditions e Temperature 10 C to 50C 14 F to 122 F e Relative Humidity 20 to 80 no condensation e Atmospheric pressure 700 hPa to 1060 hPa 4 When transporting the probe to a different field location or being returned for repair and or maintenance use the disinfected carrying case or enclosure that the probe was originally packaged in 5 If the original package is not available pack in such a way that the probe is protected 13 Care of the USB Probe USB probe s and their cables are completely sealed units The probe may be submersed in water up to the cable during normal use DO NOT OPEN ANY PROBE Be careful when handling the USB probe If the USB probe dropped on a hard s
23. es is not allowed Page 3 of 38 8000CE INS UMENG Rev 0 Z WARNING The use of a Non Medical grade AC Adapter could potentially cause harm to the system the probe the operator and or the patient 1 4 Operator qualifications The medical professional operating the USB ultrasound probe system must have a general knowledge of the use of ultrasound imaging devices and imaging protocols 2 Cleaning and disinfection Z WARNING Always disconnect the ultrasound probe system from the host computer before performing maintenance or cleaning Always follow the manufacturer s instructions when cleaning and disinfecting probes and biopsy guide adapters Do not use a surgeon s brush when cleaning probes The use of even soft brushes can damage the probe 2 1 Probe Cleaning 1 Wear protective gloves when performing the cleaning process Disconnect the probe from the system Remove any sheaths biopsy guide adapters or biopsy needle guides biopsy guide adapter if re usable the biopsy guide can be sterilized 4 Discard sheaths sheaths are single use item in a Biohazard container 5 Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any particulate matter or body fluids that remain on the probe or cable 6 To remove remaining particulates rinse with water up to the immersion point 7 Wipe with a dry cloth or wipe with a water dampened cloth to remove soap residue and then
24. hysical and functional abnormalities using established diagnostic criteria 6 USB Transducer OP 12 0 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 12 0 MHz In B mode the transducer operates over a 16 mm area as an end firing probe This device is intended for use with the USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of eyes etc and as a small organs aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 7 USB Transducer SR 7 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 7 5 MHz In B mode the transducer operates over a 29 mm area as an end firing probe This device is intended for use with the USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of peripheral vessels and as a small organs aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 8 USB Transducer EC 7 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 7 5 MHz In B mode the transducer operates over a 21 mm area as a side firing probe This device is
25. igure 5 0 00 sec 0 00 fps 7 42 24 32 mm A 0 00mm B 0 00mm 5cm 24MHz GP5MHz Figure 5 Frame The Frame Status display indicates the frame number or the elapsed seconds of the cine buffer being re played During original acquisitions the status will be displayed as Running FPS When scanning or playing back a cine buffer the FPS frames per second display will update with the current number of frames per second being displayed If the image is frozen this will display the most recent measured FPS X Y Display The X Y display shows the current pixel location in the image window This is an offset of the upper left corner of the image window Position mm The Position Display shows the position of the cursor in the image as the distance from the center of the probe face Caliper A B There are two calipers that provide linear measurements in the image window The caliper selection is found in the lower right hand corner of the screen Caliper A is the default active caliper To complete a measurement within a frozen image place the curser at the selected origin of the measure Hold down the right mouse button and drag the line to the selected termination of the measurement The A measurement will be displayed as a RED line in the image The measured distance will display at the bottom of the screen i e A 69 42mm Page 13 of 38 8000CE INS UMENG Rev 0 and B 43 26 Select the active caliper with the ca
26. ile Load Save Options Beep When Save Complete Default Data Directory C usImages ias V Update Display Settings on Load Cine Display C Frames Seconds OK Cancel Figure 2 Preferences This selection displays a dialog box to configure how images are saved and stored automatically along with other system defaults settings which are modifiable Patients If all five boxes are checked in the Patient section of Preferences the following will occur Each time a scan begins the system will require a patient name if not already entered Care should be taken to insure that the current patient s information is entered into the Exam Data dialogue box otherwise the system will continue to use the previous patient s information name id etc Each time the scan is stopped the system will automatically save the last frame image in the folder that was automatically created by the system using the patient name that was entered into the Exam Data dialogue box Page 9 of 38 8000CE INS UMENG Rev 0 File Load Save Options By checking this box the computer will beep each time an image has been saved Default Data Directory This entry should read C uslmages if saving ultrasound images on the hard drive of the computer desktop or laptop that the probe s is attached to Cine Display Determines whether the current Cine loop rate displayed in Frames or Seconds This Cine Loop display is located in the lower left hand
27. intended for use with the USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of endocavity etc and as a small organs aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria Page 38 of 38 8000CE INS UMENG Rev 0
28. intensity integral cm Supplementary information Z Z Z Z Z Z Z Z gt gt gt gt gt gt gt gt B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan Page 31 of 38 8000CE INS UMENG Rev 0 SR 7 5 MHz Probe J Im m 5 p w 17 7 13 4 m s N Ll a m gt Spatial peak temporal average intensity mW cm2 Attenuated spatial peak temporal average intensity mW cm2 Peak rarefactional acoustic pressure MPa Attenuated peak rarefactional acoustic pressure MPa 1 2 dB output beam area cm2 Equivalent aperture diameter cm Depth at max 1 30 1 30 NA attenuated pulse intensity integral cm Supplementary information Z Z Z Z Z Z Z Z Z gt gt gt gt S gt gt B Mode only with 60 degree scan angle 18 Hz scan rate and 256 lines per scan Page 32 of 38 8000CE INS UMENG Rev 0 MI Spatial peak temporal average intensity mW cm2 Attenuated spatial peak temporal average intensity mW cm2 Peak rarefactional acoustic pressure MPa Attenuated peak rarefactional acoustic pressure MPa 1 2 dB output beam area cm2 Equivalent aperture diameter cm Depth for TIS cm o Depth for TIB cm Ed Depth at max 2 0 attenuated pulse intensity integral cm Supplementary informat EC ER 7 5 MHz Probe S Scanning Non scanning Non scanning Scanning Non scanning Aaprt Ifema
29. l the signal words Warning and Caution are used regarding safety and important instructions These signal words and their meanings are as follows All users of the USB Ultrasound Probe system must understand the meanings of these signal words Signal Word Meaning Indicates an potentially hazardous situation which if not A WARNING avoided could cause injury or harm to the equipment Indicates a potentially hazardous situation which of not avoided A CAUTION may result in minor injury or harm to the equipment Indicates a potentially hazardous situation which if not avoided may result in property damage Type BF Equipment 1 2 Meaning of Safety Symbol CAUTION VAN Attention refer to Users Manual 1 3 General Cautions and Warnings Z CAUTION Probes must be cleaned after each use Cleaning the probe is an essential step prior to effective disinfection Follow the manufacturer s instructions when using disinfectants Z WARNING Do not allow sharp objects such as scalpels or cauterizing knives to touch probes or cable Z WARNING Equipment not suitable for use in the presence of flammable mixtures N WARNING If the probe is used with other devices current leakage may increase and electric shock may be caused It is the user s responsibility to ensure safety when the probe is to be used with other devices If safety cannot be ensured use of the probe with other devic
30. liper buttons in the Image Processing window Figure 6 Custom DEFAULT Image Ct Near Mid Gain Gain B oriain E x1 Is A destination SAI ES Probe Ca A origin B destination 0 GV 5T Pulse Freq Depth Puls Low Caliber A value s i i Caliper B value Caliper selection Sar Caliper CB 61 53 5 54 mm A 69 42 mm B 43 26 mm 15cm 5 0 MHz GV 5 MHz Figure 6 Zooming magnifying a Region of Interest Any area of the image window can be magnified or zoomed to fill the image window by holding down the left mouse button on the center of the area to be zoomed and then dragging the mouse to enlarge the area to be zoomed The resulting rectangle will show the extent of the image that will be displayed in the image window Zooming while imaging live or static is allowed Zooming in farther on an already enlarged image is accomplished the same by left clicking on the center of the area to be zoomed and dragging the mouse to the extent of the area to zoom The zoom will be set until a new zoom is defined or until zoom mode is turned off with the Full View button or zoom menu item Depth Mode Cm The current active depth mode is displayed and is accurate for data retrieved from disk When loading saved data this will update to indicate what the depth mode was for that data The same is true for a load a cine buffer If there is a question Page 14 of 38 8000CE INS UMENG Rev 0 regarding what the depth mode is check this di
31. ly liquid solutions Using autoclave gas EtO or other non DGH Technology approved methods will damage the probe and void the warranty 4 Mixthe disinfection solution compatible with the probe according to label instructions for solution strength A disinfectant qualified by the FDA 510 k process is recommended 5 Immerse the probe into the disinfection solution per the manufactures recommendations of duration 6 Follow the instructions on the disinfection label for the duration of probe immersion 7 Using the instructions on the disinfectant or sterilization label rinse the probe up to the point of immersion and then air dry or towel dry with a clean cloth 8 Examine the probe for damage such as cracks splitting fluid leaks or sharp edges or projections If damage is evident discontinue use of the probe and contact a customer service representative 2 3 Surface Cleaning Refer to Probe Cleaning Page 5 of 38 8000CE INS UMENG Rev 0 2 4 Surface Disinfection Refer to Probe Disinfecting 3 Acoustic Energy The effects of acoustic energy on human tissue are currently under investigation Therefore itis recommended that diagnostic ultrasound output power be set to the lowest possible levels in accordance with the principle of ALARA As Low As Reasonably Achievable See section 6 of this manual for Acoustic measurements 4 Electromagnetic Compatibility EMC The USB powered Ultrasound Probe has completed and p
32. ne Buffer Control at the upper right hand side of the screen to begin re playing the Cine Loop The Cine Loop can be re played an unlimited number of times As a method of review the left and right arrow keys on the keyboard will advance or reverse the Cine loop frame by frame All of the image controls for gain and intensity may be used to adjust the image as well as zoom to magnify areas of interest Q Cine Buffer c i i r ee Figure 4 Save Cine Saves the current cine buffer to a file All data along with the acquisition frame rate is saved for future retrieval If a patient s name was entered in the Exam Data dialogue box that patient s Cine loop folder will open Enter the filename and press Save Copy Copy s Image to Clipboard A bitmap of the currently displayed image is saved to the Windows clipboard Any setting currently in effect will be preserved in this saved image If the display image was modified by zooming and or scrolling this button will revert back to the original full view Print Prints the image that is currently displayed Full View If the image has been magnified or scrolled left right up or down the image by clicking on the Full View icon will return the image to its normal size Scan Clicking left mouse button on the Scan icon will turn the scan function on and off When the selected probe is scanning the Scan icon will have a red line through it indicating that by clicking
33. or use 1 USB Transducer GP 3 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 3 5 MHz In B mode the transducer operates over a 35 mm area as an end firing probe This device is intended for use with the USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of neonatal abdominal organs and structures including the gastrointestinal tract kidney bladder etc to aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 2 USB Transducer GP 5 0 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 5 0 MHz In B mode the transducer operates over a 32 mm area as an end firing probe This device is intended for use with the USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of neonatal abdominal organs and structures including the gastrointestinal tract kidney bladder etc to aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 3 USB Transducer SP 7 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 7 5 MHz In B mode the transducer
34. pen feda m ed Ca doll 4 2 2 Probe Disint ctng ee ipsu DW aes iatutiduc ta aetati aetesp icut e a ru iM case 4 2 3 Surlace Cle amine E M 5 24 Surface Disinfection e ea accuse creases dieu aa e a E EaR 6 3 SACOUSTIC ENERGY 5 3 utentes cedes tinea teorie bave od eid tances edet te ce le Rod 6 4 ELECTROMAGNETIC COMPATIBILITY EMC essere nnne 6 5 PRESCRIPTION DEVICE STATEMENT esses nennen innen nieo Ekaro Ear Enri SEES 6 6 TRAINING eere cedet e teure er DE dee REPOS ee LO RE UR ROPA CEP ER n 6 EE GNU DEEP 6 Fok GUIDE IER 7 T2 Install s ftWare inensis unistas n a A as asa 7 1 37 Update SO AE a a a E N MI 7 TA USB Prob Installationen na a A E S S deo M tede 7 7 9 The USB Ultrasound Probe Interface 2 eit etn eese Inn ee ara eu ree 8 Fol Man WNdOWw ERE pc ETE 8 72324 Commands Mantal ems deseaba dum vni ut ee didi eee 8 13 3 Button Bot eod dd eite o utahisit it pe eeu ceat tate ets aS 11 RA Status Dial Que cdose anes a ced Lea EM AM de LIS Ss tenes cect tated 13 7 6 Connecting and Selecting Transducer s ssssssesssesesseeesseesseesseesseeesseersseesseesseessee 15 AEE AA o E A EEEE dee NA E A E de 16 120 beltng UP anew patient eL dcs i heian tette ETERRA Agence 16 7 9 Working with the Image Controls enne enne eene 16 TOM cxdjustine the CIT aes ees teste D iege ua iut s eet uc e erc dg I7 3 0 2 Adjustimg the Intensiv 5c peccet natio eate d esse edie ten ode pur ete
35. played depth 5cm 10cm USB PROBE GP 5 0 MHZ HMN Human Abdominal Focal Point 6mm Max depth 20cm Patient contact area 32mm Displayed depth 10cm 15cm 20cm USB PROBE GP 3 5 MHZ HMN Human Abdominal Focal Point 7 5mm Max depth 20cm Patient contact area 35mm Displayed depth 10cm 15cm 20cm Page 28 of 38 8000CE INS UMENG Rev 0 APPENDIX D Summary of the acoustic quantities GP 3 5 MHz Probe Summary of the acoustic quantities GP 3 5 MHz Probe Scanning Non scanning Non scanning Scanning Non scanning Aaprt 1 cm Aaprt gt l cm S gt 38 8 38 8 Spatial peak temporal average intensity mW cm2 Attenuated spatial peak temporal average intensity mW cm2 Peak rarefactional acoustic pressure MPa Attenuated peak rarefactional acoustic pressure MPa 0 896 1 2 dB output beam area cm2 Equivalent aperture diameter Depth for TIS a E Depth at max 5 43 5 43 NA attenuated pulse intensity integral Supplementary information mu N l Z Z Z Z z Z Z Z gt gt gt gt gt gt Z Z Z Z Z Z Z Z Z Z Z Z Z gt gt gt gt gt gt gt gt gt gt gt gt gt B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan Page 29 of 38 8000CE INS UMENG Rev 0 GP 5 0 MHz Probe TABLE Summary of the acoustic quantities GP 5 0 MHz Probe
36. sed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product For more information concerning the return and recycling of this product please consult DGH Technology Inc 15 Troubleshooting If a problem is experienced with the USB probe try the suggestions as listed below e Nolmage Disconnect the Probe exit program and turn off computer Turn on the computer reconnect the Probe and Restart the program e Image not clear Adjusting the Image Controls on the right of the screen by changing Gains Intensity brightness and Contrast e Error messages Repeat all steps listed in No Image 16 Customer Service If unable to find the solution by using this manual or Help command contact DGH Technology Inc customer service or a local DGH Technology distributor Prepare to call customer service To receive the fastest possible resolution of a problem have the following information available when calling or e mailing Serial number product name and model Purchase date on the invoice Conditions under which the problem occurred Error messages that have been displayed Operating system version number Contacting customer service e Contact the local DGH Technology distributor Taking the probe s to service partner If advised to take the USB probe s to service partner be sure to provi
37. splay The depth scale is displayed on the left side of the image screen Each mark indicates one centimeter increments beginning with 1 at the top and the maximum indicated at the bottom Pulse Frequency MHz Like the Depth Mode this is updated based on the data currently being displayed in the image window When loading data from a disk this will display what the pulse frequency was when the scan occurred Probe Name The name of the current active probe is displayed based on the probe s plugged into the computer When loading data from a saved image or cine loop the name of the probe that was used to capture the scan data originally is displayed 7 6 Connecting and Selecting Transducer s Plug the Probe s into the USB 2 0 port s of the computer The Probe Controls Figure 7 is used to select the proper probe by opening the drop down menu by clicking on the right of windows menu to match with the frequency and or depth modes and to adjust the Pulse Power Figure 8 Adjust the level of pulse energy to the crystal The read out is relative from 123096 to 9210096 power Depending on what probe s have been connected to the system the available selections will vary See Help menu for more detail Probe Controls 0 GV 5 MHz x drop down menu control to select another probe if more than one probe is plugged into the computer Figure 7 Pulse Power Lo Low High Figure 8 Page 15 of 38 8000CE INS UMENG
38. the automatic filename option was selected each file will be saved using a date format and image number dd mm yyyy image nbr If the automatic save Preferences was not selected the system will require a filename for the image that has been selected to save The raw data is saved so that at anytime in the future any previously saved image can be re processed by adjusting all image controls far field mid field and near field gains intensity and contrast as if scanning real time A JPEG file is also saved with the same name that was specified for the saved image JPEG images can be zoomed and have the contrast brighter darker adjusted The JPEG format image is helpful when printing to a Windows supported printer and or if there is a need for a generic image format Open Cine Opens a previously saved cine loop If the Exam Data has been entered for the current patient the Open Cine selection will open that patient s ultrasound image folder containing the cine loops that have been saved If the Exam Data is empty Open Cine will open the folder titled uslmages This folder contains the folders for each patient that has an ultrasound history Click on the folder of the patient to review and each Cine loop will be listed Once the selected Cine Loop is Page 11 of 38 8000CE INS UMENG Rev 0 loaded this may take a few seconds for larger loops click on the white pointer in the green circle Figure 4 on the Ci
39. tion Real time Images with high definition and high resolution Image comment Save Recall browsing Image review cine for up to 256 images Image Storage CD DVD Floppy disk and USB disk Functions Printing on system printer Standard VGA TV output optional Computer PC compatible computer Page 24 of 38 8000CE INS UMENG Rev 0 APPENDIX A USB Probe System Specifications Imaging mode B Scan Functions Standard USB Port 2 0 connectivity Multiple freeze method button on probe keyboard or soft key on screen Zoom with enhanced resolution using 4 times over sampling Auto Image saves on Freeze Image resolutions 0 1 to 2 0 mm resolution Gray shades True 256 8 bits shades of gray Sector Size 60 90 or 180 degree sector Transducers High Bandwidth single element 3 5 5 7 5 and 12 MHz Depth selections 5 10 15 and 20cm Measurements 2 calibers for distance measurements Signal processing Image Post processing TGC control s near mid and far Contrast and Image Intensity controls Frame averaging Interpolation Archive functions Exam data Patient name and comments Cine buffer range 32 256 frames Open system architecture Power Requirements 5 0VDC 5 obtained from the 500mA maximum USB2 port 2 5 watts maximum Environmental Max operating temperature 40 C 104 F Min operating temperature 10 C 50 F Operating humidity range 20 80 non
40. urface it can be damaged DO NOT DISCONNECT or REMOVE USB CABLE Be sure to keep the USB probe plug dry at all times The probe should be cleaned after every use Regularly check the transducer housing front face for cracks as this may cause a loss of fluid which would impair the performance of the probe Regularly check the cable for cuts cracks and kinks This could also impair the performance of the probe Cleaning Ensure the USB probe is at room temperature rinse off any visible contamination such as scanning gel or biological substances with a detergent and tap water at a maximum of 40 C 104 F Do not use water at temperatures below 10 C 50 F Dry with a sterile cloth Maintenance Periodic testing and maintenance of the USB Ultrasound probe is NOT required J N Warning Users of this USB probe s have an obligation and responsibility to provide the highest degree of infection control possible to patients co workers and themselves To avoid cross contamination follow all infection control policies established for the office department or hospital as they apply to personnel and equipment Page 22 of 38 8000CE INS UMENG Rev 0 14 Disposal 1 Contact DGH Technology Inc before disposing of the probe 2 Concerning the WEEE label The following information is for EU member states The use of this symbol indicates that this product should not be treated as household waste By ensuring that this product is dispo
41. utton Enter a new name for the settings The current settings will be saved to the new name The new saved settings can be change later if needed Page 19 of 38 8000CE INS UMENG Rev 0 Each setting will be determined based on the active probe That is if there are two or more probes on the system each may have a separate configuration within the same named setting ISSUSB manages this Simply select the probe to be used and the settings will automatically update for that probe For example assume there is a setting called Abdominal that is routinely used for abdominal imaging There may be both a 3 5 MHz and a 5 MHz GP probe for this purpose If different depth modes or gain settings are required for each save each to the setting named Abdominal and when the probe is changed the saved settings for each will be updated If a custom setting is deleted the setting for all probes under that setting are deleted The DEFAULT setting cannot be modified or deleted This is the factory default and is defined for every supported probe to give reasonable results for a wide range of applications Use it as a starting point Create new settings and names that are intuitive and easily recognizable for recall when staring a new scanning session 10 Electromagnetic Compatibility Like other medical equipment DGH Technology USB Ultrasound Probes require special precautions to ensure electromagnetic compatibility with other electrical medical
42. wipe with a dry cloth 2 2 Probe Disinfecting A 10 6 reduction in pathogens should be reached following the disinfecting procedures in this manual and using the following recommended solutions The following disinfectants are recommended because of both its biological effectiveness as qualified through the FDA 510 k process and its chemical compatibility with DGH Technology ultrasound product materials Solutions Country Type Active ingredient FDA 510 k Page 4 of 38 8000CE INS UMENG Rev 0 Cidex USA Liquid Gluteraldehyde K934434 Cidex Plus USA Liquid Gluteraldehyde K923744 Wear protective gloves when performing the disinfecting procedure 2 Check the expiration date on the solution that is being used solution is used Use only solutions that are within the expiration date A N WARNING The type of tissue it will contact during use dictates the level of disinfection required for a device Ensure that the solution strength and duration of contact are appropriate for disinfection Be sure to follow the manufacturer s instructions A N WARNING Using a non recommended disinfection solution incorrect solution strength or immersing a probe deeper or for a period longer than recommended can damage or discolor the probe and will void the probe warranty Do not immerse probes longer than one hour Probes may be damaged by longer immersion times Disinfect probes using on
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