SeeMore™ User Guide
Contents
1. Do not use a surgeon s brush when cleaning probes Zi 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 To remove remaining particulates rinse with water up to USB connector Wipe with a dry cloth or wipe with a water dampened cloth to remove soap residue and then wipe with a dry cloth SeeMore User Guide REV 1 2 01 4 Copyright Interson Corporation 2008 2011 3 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 their biological effectiveness as qualified through the FDA 510 k process and their chemical compatibility with Interson ultrasound product materials Solutions Country Type Active ingredient FDA 510 k Cidex USA Liquid Gluteraldehyde K934434 Cidex Plus USA Liquid Gluteraldehyde K923744 1 Wear protective gloves when performing the disinfecting procedu2. The Measure Tab allows the user to choose between distance and area measurements as well as adding annotation and arrows to the exam screen Distance is the default measurement Freeze the image Using the RIGHT mouse button click on the starting point then drag the cursor to the end point Release the mouse button The measurement data is displayed on the main screen as you make the measurement This distance in mm s will be labeled on the image and displayed as D1 on the left of the imaging screen This may be repeated for as many distance measurements as you choose D1 D2 D3 D4 SeeMore User Guide REV 1 2 01 17 Copyright Interson Corporation 2008 2011 Area Click on the Area button Freeze the image Right click the mouse to trace the circumference of the object of interest The area and circumference will be displayed on the left side of the screen Zoom Magnify Image Any area of the image window can be zoomed to fill the image window by clicking 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 You can zoom while imaging live or on a static image You can zoom in farther on an already zoomed image in the same manner of left clicking on the center of the area to be zoomed and dragging the mouse to the extent of the area to zoom To return
3. Lm Entering Patient Information Click on the New Exam tab Enter information in the fields and click on Start Exam button to begin scanning Saved images cines and reports will be stored in a folder labeled with the last name of the patient within the SeeMore images folder User may select the facility and clinician to be displayed from a pull down list Click the End Exam button when exam is complete You may use the Load Patient button to navigate to an existing patient folder You may also perform a study without filling in New Exam information Click on the New Exam tab but do not fill in the data Click on Start Exam to begin scanning Saved images will be stored in a folder labeled with the date of the study SeeMore User Guide REV 1 2 01 13 Copyright Interson Corporation 2008 2011 3 AutoScan Tab l Auto Scan Adv Scan New Exam Pref Measure Intensity M Contrast D Probe Select Preset NO PROBE DI DEFAULTS Frequency Depth E 120 mHz E jo Scan n Cine Ml Im a g e _ _ _ ec Sen E Lei Cine Image Control Zwm AutoScan is the default mode for scanning The limited control options include intensity contrast depth and a choice of preset imaging settings The software auto detects the type of probe plugged in i e AB VA EC etc A number of presets are included for each probe and wil
4. Plug in the Memory Stick to one of the computer s USB 2 0 ports The following file will be displayed once you have opened the Removable Disk SeeMoreSetup exe Click on the icon SeeMoreSetup exe Follow the on screen instructions Click NEXT when prompted When installation is complete click FINISH The software is now installed Remove the Memory Stick and store it in a safe place No NOP ro Software license reference images and other useful information are also included on this Memory Stick Windows 7 users Once you click on the SeeMoreSetup exe icon installation will proceed automatically In addition to the SeeMore application short cut icons presets and reference images will also automatically be installed When the installation is complete click FINISHED Please be patient it may take several minutes SeeMore User Guide REV 1 2 01 25 Copyright Interson Corporation 2008 2011 Windows XP Users You may see a variety of prompt screens in the course of installation If you seen any of these warning screens example below select Run Next or Install and proceed as directed Open File Security Warning ES The publisher could not be verified Are you sure you want to run this software om Mame SeeMoreSetup1 2 01 exe Publisher Unknown Publisher Type Application From C Documents and Settings MarcFine My Documents IV Always ask before open
5. to normal size click on Full View or freeze unfreeze the image Annotation Right click mouse anywhere on image and type in annotation After typing text hit return enter key Pointer Right click mouse anywhere on image and release to place arrow Clear Clear All Click Clear button to erase last measurements annotations or zoom action To clear all measurements and annotations click on the Clear All button Note Optional OB calculation package and Urology calculation packages are available For calculations select desired calculation click on start and follow on screen instructions Results of calculations measurements and annotations are stored in the JPG images only not on the backscatter files Ill Scanning Plug in probe Wait a moment you will hear two beeps Launch software Click on the scan freeze button on the probe this is also the orientation button which you should point toward the patient s right side or superior head and corresponds to the orientation asterisk on the ultrasound image display window Alternately you may click on the space bar or Scan arrow on the screen to freeze or unfreeze the image A WARNING Probe s should not be connected while installing software Probe s should not be disconnected while scanning otherwise current scan data will be lost SeeMore User Guide REV 1 2 01 18 Copyright Interson Corporation 2008 2011 Image Orientation Th
6. 1 2kV 4kV 8kV_ 36 202 1 EN61000 4 Apply to all accessible Discharge 2 j 2 components contact discharge 2kV 4kV 8kV air discharge Radiated EN60601 1 80MHz 2 5GHz 36 202 1 EN61000 4 Expose all parts of EUT to field Immunity 2 3V m j 3 80 1kHz EFT EN60601 1 2kV 36 202 1 EN61000 4 None 2 4 UO Only 5 50 5kHz Conducted EN60601 1 0 15 80MHz 36 202 1 EN61000 4 None Immunit 2 j 6 d 3Vrms 0 I O Only 80 1kHz SeeMore User Guide REV 1 2 01 21 Copyright Interson Corporation 2008 2011 Guidance and Manufacturer s Declaration Electromagnetic Immunity Interson s USB Ultrasound Probes are intended for use in the electromagnetic environment specified below The customer or the user of the Interson USB Ultrasound Probe should ensure that it is used in such an environment Field strength form 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 Interson USB Ultrasound Probe is used exceeds the applicable RF compliance level the Interson USB Ultrasound Probe should be observed to verify normal operation If abnormal perf
7. OBE MV 12 0 MHz Human Vascular Phlebotomy Focal Point 0 5cm Max depth 2 0cm Patient contact area 25mm Displayed depth 3cm USB PROBE SP 7 5 MHz PI 7 5 MHz Human Superficial Anatomy Focal Point 2 0cm Max depth 10 0cm Patient contact area 20mm Displayed depth 5cm 10cm USB PROBE EC 7 5 MHz EB 7 5 MHz Human endocavity trans vaginal OB GYN Focal Point 2 5cm Max depth 10 cm Patient contact area 21mm Displayed depth 5cm 10cm USB PROBE SR 7 5 MHz VA 7 5 MHz Human Superficial Anatomy Focal Point 2 0cm Max depth 10 0cm Patient contact area 20mm Displayed depth 3cm bcm 6cm 10cm SeeMore User Guide REV 1 2 01 27 Copyright Interson Corporation 2008 2011 USB PROBE EN GP 5 0 MHz Z1 AB 5 0 MHz Human Abdominal Focal Point 6mm Max depth 20cm Patient contact area 32mm Displayed depth 10cm 15cm 20cm GP 3 5 MHz AB 3 5 MHz USB PROBE Human Abdominal Focal Point 7 5mm Max depth 20cm Patient contact area 35mm Displayed depth 10cm 15cm 20cm SeeMore User Guide REV 1 2 01 28 Copyright Interson Corporation 2008 2011 Vill APPENDIX D Summary of the Acoustic Quantities GP 3 5 MHz AB 3 5 MHz Probe I Summary of the acoustic quantities GP 3 5 MHz AB 3 5 MHz Probe cd YF m Im Scanning Non N
8. 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 INTERSON 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 PI 7 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with INTERSON USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 7 5 MHz In B mode the transducer operates over a 20 mm area as an end firing probe This device is intended for use with INTERSON 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 SR 7 5 MHz VA 7 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with INTERSON 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 w
9. TM Interson Sec More USB Probes We revolutionize imaging devices SEEMoORE USER GUIDE Copyright Interson Corporation all rights reserved 2008 2011 No part of this manual or software may be reproduced in any form or by any means electronic or mechanical including but not limited to photocopying recording or by any information storage and retrieval systems without the express written consent of Interson Rev 1 2 01 January 2011 Windows is a trademark of Microsoft Corporation Equipment Manufacturer EC Representative Interson Corporation MediTech 7026 Koll Center Parkway Suite 201 Maastrichterlaan 127 Pleasanton CA 94566 USA NL 6291 EN Vaals Phone 925 462 4948 Netherlands 800 766 4664 Phone 31 43 306 3320 Fax 925 462 4833 Fax 31 43 306 3338 Email support interson com www interson com C 0197 This user guide is applicable to but not limited to the following probes 3 5 MHz General Purpose GP AB 5 0 MHz General Purpose GP AB 7 5 MHz Small Parts SP PI 7 5 MHz Endocavity EC EB 7 5 MHz Vasoular SR VA 12 0 MHz Endo rectal ER ES d SEEMORE USER GUIDE Table of Contents KIEREN 2 A MINIMUM SYSTEM REQUIREMENTS eene nnn enne rn nnne rn rss nn nnn nsns 2 B WARNINGS SAFETY INFORMATION 2 1 MEANING OF SIGNAL Wope Re emen nnnnn nnn ns nn n nnne ar nns nan nis 2 2 GENERAL CAUTIONS AND WADNINGS menm n nnns 3 C OPERATOR QUALIFICATIONS cessere nnnm mn
10. US Federal law restricts this device to sale by or on the order of a physician 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 2 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 ll General This user guide is for the USB probe system Prior to using the probe become familiar with the operating instructions 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 Note Quality images are obtained through a combination of probe placement proper probe pressure adequate ultrasound gel and proper SeeMore settings SeeMore has the capability to save and recall presets for your specific procedures and display screen Please refer to the available reference images to learn what can be obtained with proper ultrasound technique If you are not experienced with probe placement orientation angle and pressure we recommend you attend an ultrasound training class and practice practice practice SeeMore User Guide REV 1 2 01 7 Copyright Interson Corpor
11. V Electromagnetic Compatibility Like other medical equipment Interson USB Ultrasound Probes require special precautions to ensure electromagnetic compatibility with other electrical medical devices To ensure electromagnetic compatibility EMC Interson USB Ultrasound Probes must be installed and operated according to the EMC information provided in this manual SeeMore User Guide REV 1 2 01 20 Copyright Interson Corporation 2008 2011 The Interson USB Ultrasound Probes have been designed and tested to comply with IEC 60601 1 2 2002 requirements for EMC with other devices A CAUTION Portable and mobile RF communications equipment may affect the normal function of the Interson USB Ultrasound Probes Do not use cables or accessories other than those provided with the Interson USB Ultrasound Probe as they may result in increased electromagnetic emissions or decrease immunity to such emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions amp Immunity Interson USB Ultrasound Probes are intended for use in the electromagnetic environment specified below The customer or the user of the Interson USB Ultrasound Probe should ensure that it is used in such an environment Environmental Test In Level Criteria Basic Notes Phenomena Accordance Standard to Radiated EN60601 1 Group 1 Under CISPR 11 Measure at 5 meters Emissions 2 Limit Class a Electrostatic EN60601
12. age controls for contrast and intensity Measurements and zoom may also be used to adjust the image When the image is saved a JPG image is automatically created 3 Viewing and Managing JPG Images Minimize the SeeMore application and click on the Patient Data desktop shortcut on the desktop to display the STAT Exam and Patient Data folders as described above These images contain annotations measurements and patient information not found on the raw data images They can be viewed with any standard image viewing software and are substantially smaller in size than the raw data backscatter images 4 If preference is set to Save on Freeze every time user freezes an image it will automatically be stored in the default folder User can choose whether this is triggered by pressing the scan freeze button on the probe space bar or either This Save on Freeze function is only enabled by starting a new exam 5 Cine Loops Each time you start scanning the cine buffer is cleared and will be filled with captured frames from the current scanning session To save a Cine Loop click on the Save Cine button The last number of frames of the exam will be stored in the patient s folder length can be set in preferences You can play back the entire buffer at the rate it was captured You may replay the image and stop at any frame and may save a still image from there Individual frames may be advanced using the left right keyboard arrow keys I
13. and contrast Set frequency to the highest frequency that gives adequate depth to view the target anatomy Next move all TGCs to the left and then adjust TGC1 to the right until the top third of the image begins to show saturation white pixels Similarly adjust TGC2 for the middle third of the image and TGC3 for the bottom third of the image Finally adjust intensity and contrast to optimize the display to your liking Typically TGC1 is at 25 TGC2 at 50 and TGC3 at 75 Creating and Saving Custom Probe Settings While in advanced mode the user may adjust the DGC depth gain and contrast to their liking In order to save as a preset place the cursor in the preset window and type in a new name i e clinician name or a description Example DrSmith Kidney or AB5 0MHz and click Save The DEFAULT setting cannot be modified or deleted The factory default setting is defined for every supported probe to give reasonable results for a wide range of applications This default setting should be used as a starting point You may choose to optimize the image using the suggestions detailed above in the Quality Images section and save these new settings with your own useful name You may then recall your new preferred settings each time you start a session SeeMore User Guide REV 1 2 01 16 Copyright Interson Corporation 2008 2011 l Auto Scan Adv Scan New Exam Pref Measure d le en wen sees wes L lt i
14. ation 2008 2011 The computer monitor screen is divided into two sections On the left side is the Imaging Window This displays the ultrasound scan and includes other information about the scan On the right side of the screen is the User Interface Window It contains a number of tabs that allow the user to set preferences and conduct the ultrasound exam see description and diagrams below Imaging Window User Interface Window 3 EJ Auto Scan Adv Scan New Exam Pref Measure or REN Image Orientation For Help press F1 2009 06 16 21 27 27 OminOsec OFPS 15 cm 3 5 MHz AB 3 5 MHz ISIN 1280 x 800 SeeMore User Guide REV 1 2 01 8 Copyright Interson Corporation 2008 2011 B Imaging Window Data Top Left Measurements Distance Area Calculation Results Bottom Patient name Facility Clinician Date Frequency Depth Probe type Annotation Pointer On image Image Orientation Marker Asterisk Note the asterisk in the upper left side of the sector image This corresponds to the patient s right side or superior aspect if the orientation button on the probe is pointed toward the patient s right side or superior head This may be flipped left to right using the imaging orientation button Grid lines May be displayed on the left side of the image to aid in assessing size and scale of the image viewed Default is 10 mm increments Grid lines may be adjusted within the p
15. bedded help and user manuals are all installed to the correct locations automatically if available in the same directory as SeeMoreSetup1 2 01 exe when SeeMoreSetup1 2 01 exe is executed e Presets Intensity contrast and gain presets are provided for some typical exams As additional presets are made available with subsequent versions of SeeMore existing and customer defined presets are not overwritten Presets may also be deleted SeeMore User Guide REV 1 2 01 37 Copyright Interson Corporation 2008 2011
16. d my liability be if someone stole my laptop computer or storage device What would do if my computer hard drive crashed Ultimately it is the user s responsibility to assure the security of their data Several strategies may be used to protect data 1 Control the computer and storage devices at all times They should be locked up when not under direct control of user 2 Limit access to computer to authorized users 3 Password protect computer require logon 4 Password protect any folders or files that include patient information This should have adequate encryption to prevent unauthorized viewing 5 Regularly back up your data and store in a safe place Note Interson SeeMore software does not include electronic signature control and is not meant to substitute for an electronic medical record SeeMore User Guide REV 1 2 01 36 Copyright Interson Corporation 2008 2011 XI APPENDIX G Major Feature Enhancements Version 1 2 01 Released January 7 2011 e Support for connecting and removing probes probes may be connected and removed while SeeMore software is running NOTE Probes should NOT be connected or removed while SeeMore is performing live scans data may be lost e Online revision update under the HELP pull down menu the user can check for the most recent version of SeeMore and if available is given the option to download the newer version e Most current versions of presets images cines em
17. e following information is for EU member states The WEEE label indicates that this product should not be treated as household waste By ensuring that this product is disposed 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 SeeMore User Guide REV 1 2 01 24 Copyright Interson Corporation 2008 2011 VI APPENDIX A SeeMoreTM Software Installation A WARNING Do not plug in USB Ultrasound Probe until the Software has been installed Note To check if you have the latest software Launch SeeMore application go to the Help Menu and select SeeMore Update The system will automatically check to see if you have latest software and ask permission to download latest version Minimum system Requirements Computer Operating System Windows XP Windows 7 or Mac running Windows Minimum processor 1 GHz Minimum RAM 1 GB or more USB 2 0 port Minimum display 1024 x 600 resolution with 32bit color Installing the software is a two step process Step 1 is software installation including Help Menu Reference Images Presets and PDF User Manual Step 2 is USB driver installation Note These instructions apply to Windows 7 With Vista or XP you may see different screen messages when installing software Follow on screen prompts Step 1 Software Installation
18. e sector is oriented with the probe membrane displayed at the top of the screen An asterisk orientation mark on the left side of the screen corresponds to the button on the probe which is traditionally pointed to the patient s right side or superior User may change image orientation flip left to right by clicking on the Image Orientation button at the bottom of the screen Image Controls Intensity The intensity control adjusts the overall intensity or brightness of the image Contrast The contrast control adjusts the overall contrast of the image Probe Control Settings Allow you to select the probe to use select from the available pulse frequencies and or depth modes and to adjust the pulse power Depending on what probe s you have attached to the system the available selections will vary Frequency Each probe has a center frequency but since SeeMore probes have wide band transducers they can be pulsed at higher frequencies to give better resolution with the trade off of less penetration Depth The displayed depth can be changed optimal depths vary with the pulse frequency you choose A Saving and Viewing Images There are two types of exams 1 STAT EXAM Scanning without first creating a new patient on the New Exam tab Images and cine loops may be saved and they are all stored in the STAT Images folder User must name files before saving 2 NEW EXAM The user first creates a study within the Ne
19. ector and then air dry or towel dry with a clean cloth 7 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 A WARNING Do not immerse the probe or use heat or radiation to sterilize it This will permanently damage the probe and void the warranty Draping For endocavity scanning a clean nonsterile drape or condom covering may be used Ultrasound does not penetrate through air so you must put scanning gel on the inside of the drape as well as some couplant gel or water between the outer surface of the drape and the region being scanned Visit the Interson YouTube channel for helpful instructional videos http www youtube com user IntersonCorp E Acoustic Energy The effects of acoustic energy on human tissue are currently under investigation Therefore it is 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 F Labeling The Interson GP EC amp SP family of USB powered Ultrasound Probes have completed and passed EN 60601 1 2 2007 standard SeeMore User Guide REV 1 2 01 6 Copyright Interson Corporation 2008 2011 1 Prescription Device Statement A WARNING
20. eeeeeteeeeeeseeaens 25 VII APPENDIX B INTERSON PROBES AND APPLICATIONS eene 27 VIII APPENDIX D SUMMARY OF THE ACOUSTIC QUANTITIES ccccceeeeeceeeeeeeeeseeeeesteaens 29 IX APPENDIX E INTERSON PROBES INDICATIONS FOR Uer 34 X APPENDIX F PATIENT PRIVACY AND CONFIDENTIALITY cernere 36 XI APPENDIX G MAJOR FEATURE ENHANCEMENTS eene nn nnne nnns or SeeMore User Guide REV 1 2 01 1 Copyright Interson Corporation 2008 2011 l Introduction Congratulations on your purchase of the Interson USB Ultrasound Imaging Probe the ultrasound imaging probe that plugs into the USB port of your computer Please review this user guide before you begin scanning Contact Interson or your sales representative if you have any questions Note The sale of this item is subject to regulation by the U S Food and Drug Administration and state and local regulatory agencies A Minimum System Requirements Computer Operating System Windows 7 Windows XP or Mac running Windows Minimum processor 1 GHz Minimum RAM 1 GB or more USB 2 0 port Minimum display 1024 X 600 resolution with 32 bit color B Warnings Safety Information 1 Meaning of Signal Words In this user manual 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 Interson Ultrasound Probe system must understand the meanings of these si
21. f safety cannot be ensured use of the probe with other devices is not allowed The use of a Non Medical grade AC Adapter could potentially cause harm to the system the probe the operator and or the patient Do not use in the presence of flammable anesthetics or other flammable materials SeeMore User Guide REV 1 2 01 Copyright Interson Corporation 2008 2011 C 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 D Care and Handling of Probes Although Interson probes are very durable reasonable care must be taken to avoid damaging them Handle the membrane on the tip of the probe and the cable attachment at the other end of the probe with care Keep the probe membrane away from sharp objects to avoid damage Clean and store the probe in its padded case This will protect the probe and the delicate scanning membrane Do not put stress on or use the cable to carry the probe as this may damage the probe and cable Your probe should give you many years of reliable service if these simple precautions are followed 1 Cleaning and Disinfection A 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 biopsy guide adapters
22. ginally packaged in Call Interson for an RMA number before returning probe If the original package is not available pack in such a way that the probe is protected C 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 surface 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 Maintenance Periodic testing and maintenance of the Interson USB Ultrasound probe is NOT required A 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 SeeMore User Guide REV 1 2 01 23 Copyright Interson Corporation 2008 2011 D Disposal 1 Contact Interson Corporation before disposing of the probe 2 Th
23. gnal words WARNING Indicates a potentially hazardous situation which if not avoided could cause injury or harm to the equipment Indicates a potentially hazardous situation which of not avoided may CAUTION Son TEMO result in minor injury or harm to the equipment If included on product label this symbol is specified per IEC 60601 1 A indicating BF type equipment SeeMore User Guide REV 1 2 01 2 Copyright Interson Corporation 2008 2011 General Cautions and Warnings A 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 Interson probes use very low acoustic power output and ultrasound imaging has been found in many studies to be safe when used correctly However as with all medical procedures risks and benefits must be weighed It is important to use the lowest power settings and the shortest scan times possible while attaining the needed clinical information A WARNING Do not allow sharp objects such as scalpels or cauterizing knives to touch probes or cable Equipment is not suitable for use in the presence of flammable mixtures 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 I
24. ing this file This file does not have a valid digital signature that verifies its publisher ou should only run software from publishers you trust How can decide what software to run Step 2 USB Drivers Installation Two sets of drivers will be installed one prior to launching SeeMore and one upon first launch of SeeMore For Windows 7 after plugging in a probe the system will recognize and install the first SeeMore USB driver Windows 7 will then display Your new hardware is ready for use At this point you can launch SeeMore and the second set of drivers will automatically install For Windows XP driver installation is slightly different When you plug in the probe Windows will display Found new hardware Click on Next The first set of drivers will be installed When the installation is complete click Finish Please be patient it may take several minutes Next with the probe plugged in launch the application by double clicking on the SeeMore icon on your desktop Windows will once again display Found new hardware and the second set of drivers will be installed When the installation is complete click Finish Note For Windows XP systems this process must be done for each USB port you will be using SeeMore User Guide REV 1 2 01 26 Copyright Interson Corporation 2008 2011 VII APPENDIX B Interson Probes and Applications Description Product Design Product Targeted Use USB PR
25. ith INTERSON 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 SeeMore User Guide REV 1 2 01 34 Copyright Interson Corporation 2008 2011 5 USB Transducer EC 7 5 MHz EB 7 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with INTERSON 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 intended for use with INTERSON 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 SeeMore User Guide REV 1 2 01 35 Copyright Interson Corporation 2008 2011 X APPENDIX F Patient Privacy and Confidentiality Steps You Can Take to Safeguard Your Data Ultrasound images patient data files and reports may include identifying patient information HIPAA regulations and other patient privacy and regulatory standards require that operators take reasonable care to protect this information It is important that you comply with your own hospital or clinic HIPAA guidelines regarding privacy and safeguarding patient information Ask yourselves these questions What woul
26. l generally give the best image i e Bladder Abdomen etc The preset includes TGC settings gain depth and contrast The user may create or modify existing presets and give them a unique name See Advanced tab for saving custom settings If there are multiple probes plugged in the user may select a probe from this menu Most probes have multiple frequencies and these as well as depth may be selected from this menu as well SeeMore User Guide REV 1 2 01 14 Copyright Interson Corporation 2008 2011 4 Advanced Scan Tab l Auto Scan Adv Scan New Exam Pref Measure TGC 1 Near Gain Intensity TGC 2 Mid Gain Contrast a D TGC 3 Far Gain ee a Probe Select Preset AB 3 5 MHz H ae E Frequency Depth EG DIE D el cn Scan H Cine H 2s Cine c KH Cine Image Control o Sen The user may adjust TGC time gain compensation Near Mid Far and other controls that can optimize the image but can also degrade it if the user does not adjust them correctly Intensity and Contrast controls operate in the same manner as within the AutoScan tab You can adjust the Power from low to high The default is high power and is applicable for most applications SeeMore User Guide REV 1 2 01 15 Copyright Interson Corporation 2008 2011 Quality Images Proper adjustment technique is to start by setting pulse power to maximum and centering both intensity
27. m area cm2 Equivalent mS diameter cm Depth for T S cm Depth for T B cm Depth at max attenuated pulse intensity integral cm Supplementary information B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan Z gt z gt A o eo e co Z Mi A z co co Z Z Z Z Z z Z z N pP Cc EN Co o Z gt z Z gt gt Z Z Z Z Z zZ Z z Z Z Z Z Z Z Z z Z Z Z Z Z z z S o S e eo O wo AB CH O Z gt a E o_o sp LI SeeMore User Guide REV 1 2 01 33 Copyright Interson Corporation 2008 2011 IX APPENDIX E Interson Probes Indications for Use 1 USB Transducer GP 3 5 MHz AB 3 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with INTERSON 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 INTERSON 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 AB 5 0 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with INTERSON USB ULTRASOUND
28. n nnn nn nnne nnns sna rn nnns 4 D CARE AND HANDLING OF PROBES ee enemies nn nnn nsn rn rns nana 4 1 CLEANING AND DISINFECTION eee nnnm nnne nnn nennen rsen nnns 4 2 d leziel z cx NEES ENEE ENEE 4 3 PROBE DISINFECTING i eee rehe tete Ie Petre Eve EU Eve EE DE Nee ER D Peek Y ED Ek ve D Exe OL ERR 5 E ACOUSTIC ENERGY EE 6 F luce eeh 6 1 PRESCRIPTION DEVICE GTATEMENT enn nnn nnn nn nnn nsn nan nnns 7 2 TRAINING steer eei E EDI LL E IDE UD DEA e DE 7 IE Ciz ici Re EE EEUU A SEEMORE Dispt ax 8 B IMAGING WINDOW AA 9 C USER INTERFACE WINDOW ccccccccecsececceeeceeseeeseeuseeeeeueseeeeeeseeeeeessueseeeenenaees 10 1 PREFERENCES TAB cccccccccesssecececesceeseeeseeeeeeeuseeeseeeeueseueseeeseeeeeeseeeseeeseuegs 11 2 NEW ESCVNE IT 13 3 JAUTOSGAN TAB cioe eege Ee Eege See 14 4 ADVANCED SCAN TAB cceccccceeeeceeeeeeneeeeeeenceeeceeeseeeteaeaceeseaeseeetaeaeeeeeeaseeeetaess 15 5 MEASURE Tap rnt r sinere rase es ra ene sanas ine ra rana 17 Wi s ond TTE RR RTT PETERET 18 A SAVING AND VIEWING IMAGES eene menm nnn nnn nn n rns n nnns 19 IV ELECTROMAGNETIC COMPATIBILITY EG 20 V STORAGE AND TRANSPORTATION c nrecuscenreretesor etus aa a iii 22 A STORAGE ennn a EE 22 B TRANSPORTA ION ee 23 C CARE OF THE USB PROBE en nennen nnnnnn nnn nsn na rn rns n nin nns n nnns 23 D DISPOSAL nmm 24 Vl APPENDIX A SEEMORETM SOFTWARE INSTALLATION 00ccccceseeeceeeee
29. on Imm lI Acoustic working 3 30 frequency MHz Output power mW 368 Bounded output 38 8 38 8 38 8 power mW M p 11 3 11 uH E ge 13 5 NA 13 5 temporal average intensity mW cm2 Attenuated spatial 3 98 NA peak temporal average intensity mW cm2 Peak rarefactional 1 66 1 66 NA NA acoustic pressure MPa Attenuated peak 0 896 0 896 NA rarefactional acoustic pressure MPa 1 2 dB output EN 27 beam area cm2 Equivalent aperture S 7 NA diameter Depth for TIS de E Depth for TIB SE ve Depth at max 5 43 attenuated pulse intensity integral Supplementary information B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan SeeMore User Guide REV 1 2 01 29 Copyright Interson Corporation 2008 2011 GP 5 0 MHz AB 5 0 MHz Probe TABLE Summary of the acoustic quantities GP 5 0 MHz AB 5 0 MHz Probe MI Tis ze Scanning Non Non Scanning Non scans EE scanning es a o a 00 co 2 No Po Acoustic working frequency Mcr Bounded power mW Attenuated output power mW 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 T S Depth for TIB Depth at max attenuated pulse intensit
30. ormance is observed additional measures may be necessary such as reorienting or relocating the Interson USB Ultrasound Probe system V Storage and Transportation A Storage When the Probe is not being used it should be stored in a clean dry area A CAUTION Do not store the probe in the shipping case unless it has been properly disinfected The probe case may become a source of contamination 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 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 SeeMore User Guide REV 1 2 01 22 Copyright Interson Corporation 2008 2011 B Transportation Never carry the probe by the cable The cable could disconnect from the probe allowing it to drop and possibly damaging the probe Never bend the USB cable in a tight radius This could result in damage to the cable 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 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 ori
31. re 2 Check the expiration date on the solution that is being used Use only solutions that are within the expiration date A WARNING The type of tissue the probe 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 on the cleaner 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 only liquid solutions Using autoclave gas EtO or other non Interson approved methods will damage the probe and void the warranty 3 Mix the disinfection solution compatible with the probe according to label instructions for solution strength A disinfectant qualified by the FDA 510 k process is recommended 4 Immerse the probe into the disinfection solution per the manufacturer s recommended duration of time SeeMore User Guide REV 1 2 01 5 Copyright Interson Corporation 2008 2011 5 Follow the instructions on the disinfection label for the duration of probe immersion 6 Using the instructions on the disinfectant or sterilization label rinse the probe up to the USB conn
32. references tab SeeMore User Guide REV 1 2 01 9 Copyright Interson Corporation 2008 2011 C User Interface Window There are five tabs in the User Interface Window Preferences Pref New Exam Advanced Scan Adv Scan AutoScan Measure Each will be discussed in the following sections At the bottom of the User Interface Window available regardless of which tab you select are the Save Image Load Image Save Cine and Load Cine controls These functions allow users to save current screen image s or recall prior exams Cine play stop allows user to review saved frames and save the frozen image There is a Zoom button details of operation described on page 18 The Image Orientation button flips the image right to left To freeze an image click on the green Scan arrow in the image box Note you may also freeze an image by clicking on the scan freeze button on the probe or by depressing your computer s space bar To play cine loop click on the green arrow You may review frame by frame by using arrow keys You may then save any of the still images within the loop Loes E toed re oy zum SeeMore User Guide REV 1 2 01 10 Copyright Interson Corporation 2008 2011 1 Preferences Tab Auto Scan Adv Scan New Exam Pref Measure Facility DI OHSU Add Clinician Smith Remove Grid Lines Image Store 10 mm Patient Data Browse Cine Frames Auto Save EN ES E Ei
33. stic working 4 75 frequency MHz Output power mW 17 Bounded output 13 4 power mW Attenuated output 11 5 power mW 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 0 64 beam area cm2 Equivalent aperture diameter ET Depth for TIS Depth for TIB c Depth at max attenuated pulse intensity integral gt gt M M A Co IN oo o e ho T i o Z Z Z Z Z Z Z Z Z Z Z Z O 858 5 5 s s l l l Z gt NAINA A A m T cm Supplementary information B Mode only with 60 degree scan angle 18 Hz scan rate and 256 lines per scan o Sg o N co E N o Z Z Z gt gt gt SeeMore User Guide REV 1 2 01 32 Copyright Interson Corporation 2008 2011 EC 7 5 MHz EB 7 5 MHz Probe TABLE Summary of the acoustic quantities EC 7 5 MHz EB 7 5 MHz Probe TIS TIB Scanning Non Non Scanning n scanning Asi om MI TIB Non scanning Acoustic working frequency cM Output power m Bounded Zen power mW Attenuated output power mW 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 bea
34. ther Centerline Biopsy Guide Invert Image Import Settings Export Settings Report Setup Ten M Zoom SeeMore User Guide REV 1 2 01 11 Copyright Interson Corporation 2008 2011 Select the Preferences tab in the user interface window and fill out the following 1 Facility e Click within window and type in name e Click on the Add button You may enter as many names as you like e To delete a name click Remove 2 Clinician Same as above 3 Cine Frames a Choose frames saved 32 64 128 or 256 Default is 32 frames More frames longer length more memory is used b Grid lines options Off 10 mm 5mm 2mm scale Default is 10 mm scale 4 Image Store a Location of folder to store images on Browse to modify location and folder 5 Auto Save a Save image on button press freeze b Save on space bar press c Saveon either d Off default 6 Invert image flips image vertically Center Line Biopsy Guideline The Center Line radio button toggles on and off a center line The Biopsy Guideline only works with the endocavity probe and is used in conjunction with a biopsy guide SeeMore User Guide REV 1 2 01 12 Copyright Interson Corporation 2008 2011 2 New Exam Tab l Auto Scan Adv Scan New Exam Pref Measure Patient Info Last Name NEED Facility posu rj First Name NEED Clinician mh v Birth Date NEED ID Se s Notes
35. w Exam tab by filling in the form and clicking on Start Exam If a last name is entered a folder with that name is created within the Patient Data folder and all images saved during the study are located there If an exam is created but no last name entered a folder with the current date is created and all images will be located there User must Stop Exam at the conclusion of the study SeeMore User Guide REV 1 2 01 19 Copyright Interson Corporation 2008 2011 A desktop shortcut link to a folder called Patient Data displays both the STAT Images Exam Folder and named Patient Data Folders Within these folders the user may select JPG files for printing or may send them to an external drive or attach to emails using the Windows Send To command right click on image and select Send To option There are several ways to save images 1 First freeze the image and then click on the Save Image button It will be stored in a folder as described above You may later rename the image or change location of storage when saved manually Images are stored in both raw data format back scatter images file type bs as well as jpg format JPG images are compressed and take less storage They can easily be printed or emailed 2 Viewing and Managing Raw Data Backscatter Images Click on the Review Image button A high resolution image will be displayed which may be manipulated post processed to some extent The im
36. y integral Supplementary information B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan S Z Z z z SeeMore User Guide REV 1 2 01 30 Copyright Interson Corporation 2008 2011 SP 7 5 MHz VA 7 5 MHz Probe Probe TABLE Summary of the acoustic quantities SP 7 5 MHz Probe VA 7 5 MHz J MI TIS Scanning Non Non Scanning Non W ve wm DS Ju Im NA NA NA i NA Acoustic working frequency M Output power m Bounded ee 11 4 power mW Attenuated output 10 6 power mW 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 mw diameter cm Depth for T S cm Depth for T B cm Depth at max attenuated pulse D O1 gt 9 4 ol N P N N NA Im NA NA LL NA NA intensity integral cm Supplementary information B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan 1 LET o Oo eo A D w C5 SeeMore User Guide REV 1 2 01 31 Copyright Interson Corporation 2008 2011 SR 7 5 MHz VA 7 5 MHz Probe TABLE Summary of the acoustic quantities SR 7 5 MHz VA 7 5 MHz Probe Sg Ge ees Scanning Non Non Scanning Non ie scanning eelere MI z Acou
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