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1. 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 the GlobalMed 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 GlobalMed 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 01 9911 00 ClearProbe User Guide Revision 5 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 the GlobalMed 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 GlobalMed 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 MHz2. Appendix D GlobalMed Probes and their Applications Description Product Design Product Targeted Use USB PROBE GP 3 5 MHz AB 3 5 MHz Human Abdominal Focal Point 7 5 mm Max depth 20 cm Patient contact area 35 mm Displayed depth 10 cm 15 cm 20 cm USB PROBE GP 5 0 MHz AB 5 0 MHz Human Abdominal Focal Point 6 mm Max depth 20 cm Patient contact area 32 mm Displayed depth 10 cm 15 cm 20 cm USB PROBE SP 7 5 MHz PI 7 5 MHz Human Superficial Anatomy Focal Point 2 0 cm Max depth 10 0 cm Patient contact area 20 0 mm Displayed depth 5 cm 10 cm USB PROBE MV 12 0 MHz Human Vascular Phlebotomy Focal Point 0 5 cm gt Max depth 3 0 cm Patient contact area 29 0 mm Displayed depth 3 0 cm USB PROBE NV 12 MHz Human Near Field Vascular Focal Point 0 5 cm Max depth 3 0 cm Patient contact area 29 0 mm Displayed depth 3 0 cm USB PROBE SR 7 5 MHz VA 7 5 MHz Human Superficial Anatomy Focal Point 2 0 cm Max depth 10 0 cm Patient contact area 20 mm Displayed depth 3 cm 5 cm 6 cm 10 cm USB PROBE EC 7 5 MHz EB 7 5 MHz Human Endocavity Trans Vaginal OB GYN Focal Point 2 5 cm Max depth 10 cm Patient contact area 21 mm Displayed depth 5 cm 10 cm 01 9911 00 ClearProbe User Guide Revision 5 Appendix
3. This device is a hand held single element mechanical sector probe intended for transcutaneous use with the GlobalMed 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 the GlobalMed USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of neonatal abdominal organs and structures including the gastrointestinal tract kidney bladder etc peripheral vessels and small organs to aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 4 USB Transducer MV 12 0 MHz NV 12 0MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the GlobalMed 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 GlobalMed USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of peripheral vessels and as small organs to aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 5 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 the GlobalMed USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 7 5 MHz In B mode the
4. 500 mA max 2 5 watts max obtained from the USB 2 0 port Environmental e Max operating temperature 35 C 95 F e Min operating temperature 10 C 50 F e Operating humidity range 20 80 non condensing Storage Temperature 10 C to 50 C 14 F to 122 F Probe Dependent A N WARNING The use of a non EN 60601 2 approved AC Adapter could potentially cause harm to the system the probe the operator and or the patient A N WARNING The use of non ISO 10993 series of standards off the shelf Ultrasound Transmission Gel could potentially cause harm to the system the probe operator and or the patient 01 9911 00 ClearProbe User Guide Revision 5 Appendix C Computer System Specifications Open System Architecture Processor Memory Video Chipset Video Memory Display Digital Ports Keyboard Mouse AC Adapter Battery Type Operating System Software Warranty Special Options A N WARNING prone 12 1 TFT XGA 1024x768 or greater 2 USB 2 0 Port s full speed 1 year for the ultrasound probe N A Do not use cables or accessories other than those provided with the GlobalMed USB ultrasound probe as this may result in increased electromagnetic emissions or decrease immunity to such emissions The use of a Non Medical grade AC Adapter could potentially cause harm to the system the probe the operator and or the patient 01 9911 00 ClearProbe User Guide Revision 5
5. Control the computer and storage devices at all times They should be locked up when not under direct control of user Limit access to the computer to authorized users Password protect computer require login Password protect any folders or files that include patient information This should have adequate encryption to prevent unauthorized viewing Regularly back up your data and store in a safe place Note GlobalMed ClearProbe software does not include electronic signature control and is not meant to substitute for an electronic medical record 01 9911 00 ClearProbe User Guide Revision 5
6. D oo D ziziz z Z 2 Z z z 7 REMEI zziz zZ Z Bai b E E kik i Z gt Z J wo gt Z Z gt oO O D oo M ais N o 01 9911 00 ClearProbe User Guide Revision 5 Summary of the acoustic quantities ER 12 0 MHz ES 12 0 MHz Ml TIS TB Non Scanning Non ae scanning Aaprt gt 1 cm TIS Scanning TIS Non scanning Aap 1 cm Acoustic working 4 60 60 frequency MHz Output power mW 23 5 Bounded output 19 8 power mW Attenuated output 12 4 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 _ 0 64 area cm2 Equivalent aperture diameter or Depth for TIS Depth for TIB c 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 Based on comparative analysis N N or oj o Z gt Z gt ow _ c g B N A Z gt Z gt Z Z w D oo D ziziz z Z 2 Z z z 7 EERIE zziz zZ Z ee Z gt Z N w e gt gt oO O D oo M ais N o 01 9911 00 ClearProbe User Guide Revision 5 Summary of the acoustic quantities MV 12 0 MHz NV 12 0 MHz Index Acoustic working frequency M Output power m Bounded
7. MPa Attenuated peak 1 35 rarefactional acoustic pressure MPa 1 2 dB output beam area cm2 Equivalent aperture diameter cm2 Depth for TIS Depth for TIB Depth at max attenuated pulse intensity integral Supplementary information B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan oO 00 ne 9 2 2 gt Z gt Z gt Z Z gt Z gt Z 3 93 S Se aor 1 cm Aap gt 1 cm a ae HHF aa es i SS 01 9911 00 ClearProbe User Guide Revision 5 Summary of the acoustic quantities SP 7 5 MHz PI 7 5 MHz Index Acoustic working frequency MHz Output power mW Bounded output 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 or Depth for TIS Depth for TIB c Depth at max attenuated pulse intensity integral cm Supplementary information Z Z Z Z Z Z Z Z Z Z TIS Non og 1 cm TIS Non ae Aaprt gt 1 cm TB Scanning Non scanning D Sz gt Z gt Z gt gt Z gt Z Z Z gt oo M aia B Mode only with 90 degree scan angle 15 Hz scan rate and 256 lines per scan 01 9911 00 ClearProbe User Guide Revision 5 Summary of th
8. Patient ecen Pit _ t Start Exam posts the current patient information to the Status Save Remove a Window and makes a patient folder in the Documents ClearProbe Data Patient Data directory Images and calculations are stored to this folder Start and then stop freeze a scan You may use either the Scan button on the screen the button on the probe or the keyboard space bar Images are saved each time Save Image is pressed Prior to pressing Save Image you may scroll to a specific image by using the arrow keys on the keyboard or the scroll wheel on the mouse You may add measurements annotations and calculations prior to pressing Save Image To end a patient exam press Stop Exam After an exam is completed Print will print a single page report for the selected patient Last Name The report is driven from a customizable template The standard template prints a single page report of the patient information and the first four saved images The report template may be modified to arrange text and images and to modify the number of images that are included in the report Contact GlobalMed or your distributor to learn how to modify the report template Images calculations and measurements that are conducted here in the Patient tab are automatically associated with a specific patient if Start Exam has been pressed To make a calculation or measurement that is not associated with a specific patient select the Measure
9. image A Biopsy Guide reference line can be displayed if an endocavity probe is the selected probe Cine Frames allows the user to specify the number of frames that are buffered for replay 32 64 128 256 512 1024 or more may be selected As the frame rate is approximately 15 frames per second these equate to approximately 2 4 8 16 32 or 64 seconds of buffered frames The maximum number of Cine Frames depends on your installed memory and is automatically set on ClearProbe startup The keyboard arrow keys or the mouse wheel will scroll through cine frames Splash Video enables an included video describing the features and capabilities of ClearProbe to be played when ClearProbe starts Audio Prompt enables included audio measurement prompts to be played during a bladder volume calculation Display Scaling controls the size of the ClearProbe application window The optimal scale percentage is automatically calculated Setting display scaling larger than optimal will cause Windows to add pixels to the image data The clearest image is obtained with the smallest scaling Enter a value press return close and reopen ClearProbe to change the display scaling Orientation flips the image right and left Radiologists convention is the orientation mark identifies the right side or head of a patient Invert Image flips the image up and down 01 9911 00 ClearProbe User Guide Revision 5 6 5 Measure Tab The Measure tab is used to add m
10. 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 devices is not allowed A N WARNING The use of a non EN 60601 2 approved AC Adapter could potentially cause harm to the system the probe the operator and or the patient A N WARNING Do not touch the USB probe System s USB cable connector and the patient simultaneously A N WARNING USB Probe System is not to be used with HF surgical equipment A N WARNING Do not submerse USB Probe System in water A N WARNING No modification of this equipment is allowed Attempting to modify or service the equipment may result in safety hazards and performance degradation and or failure 01 9911 00 ClearProbe User Guide Revision 5 3 4 Symbology The following symbols may be used on GlobalMed labeling Symbol for Serial Number Symbol for Part Number Symbol indicating the date of manufacture Type BF Equipment Follow Operating Instructions 3 5 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 Do not plug in the ultrasound probes until the software has been fully installed See software installation guide in Appendix A page 18 Do not
11. most recent frames After stopping a scan the most recent frames can be replayed by pressing the Cine play button The number of frames that are automatically saved in the Cine frames buffer can be set in the Settings tab Image Save stores the current displayed frame of native format scan data and also a jpeg with measurements and annotations Image Load recalls a saved frame of native format raw scan data Cine Save stores the buffer of most recent scan frames Cine Load recalls a previously saved buffer of the most recent scan frames 01 9911 00 ClearProbe User Guide Revision 5 6 3 Patient Tab The Patient tab is where new patients are entered and selected prior to starting an exam New patient information can be typed over current information or Clear Fields will remove all displayed information without deleting a patient from the database Y Auto Scan Adv Scan Patient Settings measure A new patient can be entered or an existing patient can be edited Patient Info After editing or entering the patient information select Save and ET Fecity fcwn l follow the prompts to add as a new patient or edit the current patient BithDate RAMS see ws Facility and Clinician are selected and saved with the patient They i are entered and edited in the Settings tab Sort alphabetically sorts the database by Last Name If Sort is not checked patients are displayed in the order they were entered
12. tab make calculations and measurements and optionally save and print single images 01 9911 00 ClearProbe User Guide Revision 5 6 4 Settings Tab The Settings tab is used to configure the functions of ClearProbe NY Auto Scan Adv Scan Patient Settings Measure In the Facility block you can Add and Remove either Facility or Clinician names To remove a name highlight the facility or clinician name and select Remove To add a new name type over an existing name and select Add The previous entry is not edited the new entry is added GI om SP oF D cenere I Report Copy lists any connected storage drives and allows you to select a location to store a duplicate copy of patient exams Splash Video Audio Prompt tension _nerinsse Patient Data Folder specifies the location for patient data and exams You can select Browse and modify the default location By specifying a network folder ClearProbe will automatically make all patient folders in and send all patient data to the network location Grid displays reference marks on the left side of the Image Window Auto Save specifies whether the space bar or the probe button automatically saves images to the patient s folder during an exam The default is OFF as the user has much more control over which image to save using Save Image after selecting Start Exam in the Patient tab Centerline displays a reference line in the center of the
13. use in the presence of flammable anesthetics or other flammable materials GlobalMed 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 3 6 Care and Handling of Probes Although GlobalMed 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 01 9911 00 ClearProbe User Guide Revision 5 3 7 Cleaning and Disinfection a WARNING Always disconnect the ultrasound probe system from the host computer before performing maintenance or cleaning AN WARNING Always follow the manufacturer s instructions when cleaning and disinfecting probes and biopsy guide adapters UN WARNING Do not use a surgeon s brush when cleaning probes The use of even soft brushe
14. 0601 1 2 80MHz 2 5GHz 36 202 1 j EN61000 4 3 Expose all parts 3V m 80 1kHz of EUT to field EFT EN60601 1 2 2kV 36 202 1 j EN61000 4 4 None 1 0 Only 5 50 5kHz Conducted Immunity EN60601 1 2 0 15 80MHz 36 202 1 j EN61000 4 6 None 1 0 Only 3Vrms 80 1kHz Guidance and Manufacturer s Declaration Electromagnetic Immunity GlobalMed s USB Ultrasound Probes are intended for use in the electromagnetic environment specified below The customer or the user of the GlobalMed 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 GlobalMed USB Ultrasound Probe is used exceeds the applicable RF compliance level the GlobalMed 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 GlobalMed USB Ultrasound Probe system 01 9911 00 ClearProbe User Guide Revision 5 9 Storage When the Probe is not being used it should be stored in a clean d
15. ClearProbe GlobalMed USB Ultrasound User Guide Copyright GlobalMed Corporation all rights reserved 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 GlobalMed Windows is a trademark of Microsoft Corporation ClearProbe USB Ultrasound is a trademark of GlobalMed Equipment Manufacturer GlobalMed Corporation 15020 North 74th Street Scottsdale AZ 85260 USA Phone 1 480 922 0044 Fax 1 480 922 1090 Email support GlobalMed com Website www GlobalMed com Information in this document is subject to change without notice 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 Vascular SR VA 7 5 MHz Endorectal ER ES 12 0 MHz Endorectal ER ES 12 0 MHz Micro Vascular MV NV Table of Contents 1 Introduction 2 Minimum System Requirements 3 Warnings Safety Information 3 1 Meaning of Signal Words 3 2 Meaning of Safety Symbols 3 3 General Cautions and Warnings 3 4 Operator Qualifications 3 5 Care and Handling of Probes 3 6 Cleaning and Disinfection 3 7 Probe Cleaning 3 8 Probe Disinfecting 3 9 Surface Cleaning 3 10 Surface Disinf
16. E Summary of the Acoustic Quantities Summary of the acoustic quantities GP 3 5 MHz AB 3 5 MHz Scanning Non Non Scanning Non a warn scanning a Acoustic working a 30 frequency ae serfs pux fu fos par ps Bounded sa 3 5 3 Attenuated i 1 3 111 3 poner rw ppe pee e Spatial a 13 5 NA temporal average intensity mW cm2 Attenuated spatial 3 98 3 98 3 98 NA NA peak temporal average intensity mW cm2 Peak rarefactional 1 66 1 66 NA 1 66 NA NA acoustic pressure MPa Attenuated peak 0 896 0 896 NA NA 0 896 NA NA rarefactional acoustic pressure MPa 1 2 dB output beam 27 2 27 area cm2 ei toe N T Equivalent aperture 1 7 Eem fx be e ff ee ae a ae a Sa oo m Ja fo INA Depth at max oa 43 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 01 9911 00 ClearProbe User Guide Revision 5 Summary of the acoustic quantities GP 5 0 MHz AB 5 0 MHz ms S TB Scanning Non Non Scanning Non scanning scanning scanning apt 1 Cm apt gt 1 Cm Acoustic working z frequency M Output power m 38 3 all jo CNA c 6 ne Bounded iat 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
17. Help in the upper left corner of SeeMore and select Help Topics 6 1 Auto Scan Tab The Auto Scan tab is the default view You may select different presets and adjust basic functions such as depth frequency intensity and contrast from this tab Auto Scan Adv Scan Patient Settings Measure YOU May adjust the Intensity and Contrast It is typically best to leave these in the center Probe Select identifies all connected probes and enables you to select which probe you would like to use Select the pull down arrow to view the list of connected probes Preset enables you to select from any included presets of ultrasound parameters A specific preset contains Intensity Contrast Near Gain Mid Gain Far Gain Frequency Depth and Power The list of available presets changes based on the probe that is selected Presets are saved and deleted in the Adv Scan tab Frequency allows you to select from available pulse frequencies Pulse frequencies are probe specific and as such different probes may have different pulse frequencies As image resolution is better at higher frequencies always use the highest pulse frequency that allows you to scan to your desired depth Depth changes the displayed depth range Depth ranges are dependent on the probe and the selected pulse frequency Scan starts and stops the scan The scan button on the probe and the keyboard s space bar will also start and stop the scan SeeMore automatically s
18. Memory Stick and store it in a safe place Do NOT launch the ClearProbe application the drivers need to be installed Connect the ultrasound probe to an available USB 2 0 port Wait for the first driver to install Windows 7 will confirm the installation Launch the ClearProbe application using the shortcut on the desktop The second driver will install Windows 7 will confirm the installation The ClearProbe application will now launch and you are ready to scan 01 9911 00 ClearProbe User Guide Revision 5 Appendix B GlobalMed 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 4 times over sampling e 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 50 60 or 90 degree sector Transducers High Bandwidth single element 3 5 MHz 5 MHz 7 5 MHz 12 MHz 15 MHz and 24 MHz Depth Selections 3 5 6 10 15 and 20 cm depths Measurements Distance area volume measurements Signal Processing TGC controls near mid and far Contrast and image intensity controls Frame averaging Interpolation Archive Functions Exam data Cine buffer range 32 256 frames Open system architecture Power Supply Requirements DC 5 0 VDC 5 at
19. Window displays the ultrasound scan and includes measurements calculations and annotations The Status Window displays patient information for the active exam and details about the probe and its settings On the right side of the screen is the User Interface Window It contains a number of tabs to adjust the image input patient and exam information set preferences and perform measurements and calculations Each of these tabs and their functions are described in detail in this User Guide Imaging Window User Interface Window t Auto Scan Adv Scan Patient Settings Measure 1 2012 06 20 18 21 59 0 min 0 sec Status Window Note the blue dot on the upper left side of the image This blue dot corresponds to the scan freeze and image orientation button on the probe The radiologist s convention is that the orientation mark on the image identifies the patient s right side or the patient s head The image can be flipped and or inverted in the Settings tab 01 9911 00 SeeMore User Guide Revision 5 6 User Controls The User Interface Section on the right side of the screen contains five tabs Auto Scan Adv Scan Patient Settings and Measure Each of these tabs has its own page in this Quick Start Guide Video and embedded help are also available for each of these tabs To access Video Help select a tab and then use the Help pull down in the upper left corner of SeeMore and select Video Help To access embedded help select
20. amily SP USB Probe Family 5 or 5 mm whichever is greater EC USB Probe Family 01 9911 00 ClearProbe User Guide Revision 5 7 Saving Viewing and Printing Images There are a variety of ways to save view and print images from the ClearProbe application As saved images are also stored in the jpeg format they can be viewed and printed with a variety of Windows applications Saving There are many ways that images can be saved At the bottom of each control tab on the left is the Image Save function This automatically saves the current frame as a backscatter image raw data Image Save also automatically saves the current image frame as a jpeg and includes any added measurements calculations and annotations If a patient exam is started images are saved automatically in the patient folder whenever you freeze the image with either the probe button or space bar This Auto Save feature is configured in the Settings tab If a patient exam is started you can save images using Save Image just below the Start Exam button Refer to the Patient Tab and Patient Tab Video Help Viewing To review jpeg images minimize or close ClearProbe and click on the desktop folder labeled Patient Data You can select and open a specific jpg image To Review backscatter images in the ClearProbe application click on the Load Image button at the bottom of any Control Tab Select a specific bs image The current image in the i
21. aves the most recent frames After stopping a scan the most recent frames can be replayed by pressing the Cine play button The number of frames that are automatically saved in the cine frames buffer is selected in the Settings tab Image Save stores the current displayed frame of native format scan data and also a jpeg with measurements and annotations Image Load recalls a saved frame of native format raw scan data Cine Save stores the buffer of most recent scan frames Cine Load recalls a previously saved buffer of the most recent scan frames 01 9911 00 SeeMore User Guide Revision 5 6 2 Advanced Scan Tab The Adv Scan tab has the same functionality as the Auto Scan tab as well as the capability to adjust the image s gains and pulse power and save presets Auto Scan Adv Scan Patient Settings Measure IN the right hand column of sliders you can adjust the Intensity and Contrast Typically you will leave these in the center Power controls the probe s pulse power Typically Power will be at the maximum unless the image is saturated with the Gains centered In the left hand column of sliders you can adjust three gains Start with all three gains in the center If the image is saturated lower the H Power Lower Power typically provides better images when MEE imaging a bladder or fetus Near Gain adjusts the first third of the image Mid Gain adjusts the middle third and Far Gain the last third An alternative adju
22. ce 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 one diameter cm Depth for TIS Depth for TIB c Depth at max attenuated pulse intensity integral cm Supplementary information TIS TIS Non scanning apt gt 1 Cm TIB Scanning Non scanning Non og Aap 1 CM Z N N Z gt Z Z gt Z gt Z ZZ Z Z Z Z gt os Peston ae Trt mo p m aa B Mode only with 60 degree scan angle 15 Hz scan rate and 256 lines per scan 01 9911 00 ClearProbe User Guide Revision 5 Appendix F GlobalMed ClearProbe Probes Indications for Use ClearProbe USB Probes GP 3 5 MHz AB 3 5 MHz GP 5 0 MHz AB 5 0 MHz SP 7 5 MHz PI 7 5 MHz MV 12 MHz NV 12 MHz SR 7 5 MHz VA 7 5 MHz EC 7 5 MHz EB 7 5 MHz ER 7 5 MHz ES 7 5 MHz ER 12 0 MHz ES 12 0 MHz Clinical Application Ophthalmic Fetal Abdominal Intra Operative Specify Intra Operative Neurological Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans esophageal Trans Rectal Trans Vaginal Trans Urethral Intra Vascular Peripheral Vascular Laparoscopic Muscular Skeletal Conventional Muscular Skeletal Superficial Others Specify
23. cted 01 9911 00 ClearProbe User Guide Revision 5 11 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 and 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 GlobalMed USB ultrasound probe is NOT required A N WARNING Do not use cables or accessories other than those provided with the GlobalMed USB Ultrasound Probe as this may result in increased electromagnetic emissions or decrease immunity to such emissions A N WARNING Users of this USB probe s have an obligation and responsibility to provide the highest degree of infection control po
24. dB output beam _ 0 64 area cm2 Equivalent aperture diameter or Depth for TIS Depth for TIB c 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 N N or oj o Z gt Z gt ow _ c g B N A Z gt Z gt oo D oo D ziziz z Z 2 Z z z 7 REMEI zziz zZ Z ee Z gt Z J wo gt Z Z gt oO O D oo M ais N o 01 9911 00 ClearProbe User Guide Revision 5 Summary of the acoustic quantities ER 7 5 MHz ES 7 5 MHz Ml TIS TB Non Scanning Non ae scanning Aaprt gt 1 cm TIS Scanning TIS Non scanning Aap 1 cm Acoustic working 4 60 60 frequency MHz Output power mW 23 5 Bounded output 19 8 power mW Attenuated output 12 4 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 _ 0 64 area cm2 Equivalent aperture diameter or Depth for TIS Depth for TIB c 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 N N or oj o Z gt Z gt ow _ c g B N A Z gt Z gt oo
25. e acoustic quantities SR 7 5 MHz VA 7 5 MHz Index Acoustic working frequency MHz Output power mW Bounded output 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 2 27 rarefactional acoustic pressure MPa 1 2 dB output beam area cm2 Equivalent aperture diameter or Depth for TIS Depth for TIB c Depth at max attenuated pulse intensity integral cm Supplementary information Z Z Z Z Z Z TIS Scanning Non e 1 cm TIS TB Non Scanning Non ae scanning Aaprt gt 1 cm 17 13 x N 36 2 gt Z gt Z gt Z Z gt Z gt Z oo M T B Mode only with 60 degree scan angle 18 Hz scan rate and 256 lines per scan 01 9911 00 ClearProbe User Guide Revision 5 Summary of the acoustic quantities EC 7 5 MHz EB 7 5 MHz Ml TIS TB Non Scanning Non ae scanning Aaprt gt 1 cm TIS Scanning TIS Non scanning Aap 1 cm Acoustic working 4 60 60 frequency MHz Output power mW 23 5 Bounded output 19 8 power mW Attenuated output 12 4 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
26. easurements and annotations to an image as well as perform any included calculations If calculations are not included contact GlobalMed about available calculations Bladder Volume Prostate Volume Crown Rump Gestational Sac Femur Length Head Circumference Abdominal Circumference and Bi Parietal Diameter are all available Auto Scan Adv Scan Patient Settings Measure There are four types of measurements available Distance is invoked by either placing and dragging your finger or simply left click and drag on the image window Similarly a perfect Circle can be drawn or a random shape with Area freehand To draw a smooth shape use Area 5 points and select five points on the image ClearProbe will smoothly connect the five points Annotate and Pointer are used to label items on the image Font Size can be changed to suit your preference Clear removes the most recent measurement or annotation one at a time Clear All removes all calculations measurements and annotations If calculations are available they can be selected using the Calculate pull down Pressing Start provides text prompts underneath the calculations window If a patient exam is open the calculation images will be saved to the patient folder If not you can save the image with calculations measurements and annotations by using Image Save Statement of Accuracy Accuracy of distance measurements are displayed in the table below GP USB Probe F
27. ection 3 11 Acoustic Energy 3 12 Electromagnetic Compatibility EMC 3 13 Prescription Device Statement 3 14 Training 4 General 5 ClearProbe Display 6 ClearProbe User Controls 6 1 Auto Scan Tab 6 2 Advanced Scan Tab 6 3 Patient Tab 6 4 Settings Tab Measure Tab Saving Viewing and Printing Images Electromagnetic Compatibility 9 Storage 10 Transportation 11 Care of the USB Probe 12 Disposal Appendix A ClearProbe Software Installation Appendix B GlobalMed Probe System Specifications Appendix C Computer System Specifications Appendix D GlobalMed Probes and their Applications Appendix E Summary of the Acoustic Quantities Appendix F GlobalMed ClearProbe Probes Indications for Use Appendix G Patient Privacy and Confidentiality 01 9911 00 ClearProbe User Guide Revision 5 O WOON NN NNN OT_U M FP HPWWNN DN PY Introduction Congratulations on your purchase of the GlobalMed 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 GlobalMed or your sales representative if you have any questions Note There is also an embedded Help Guide in the ClearProbe software Note The sale of this item is subject to regulation by the U S Food and Drug Administration and state and local regulatory agencies Minimum System Requirements Computer Operating System Windows 7 8 Minimum processor 2 5 GH
28. ehyde K923744 1 Wear protective gloves when performing the disinfecting procedure 2 Check the expiration date on the solution that is being used solution is used 3 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 A N WARNING Do not immerse probes longer than one hour Probes may be damaged by longer immersion times A N WARNING Disinfect probes using only liquid solutions Using autoclave gas EtO or other non GlobalMed approved methods will damage the probe and void the warranty 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 Immerse the probe into the disinfection solution per the manufacturer s recommendations of duration Follow the instructions on the disinfection label for the duration of probe immersion Using the instructions on the disinfectant or sterilization label rinse the probe
29. ional abnormalities using established diagnostic criteria 8 USB Transducer ER 12 0 MHz ES 12 0 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the GlobalMed USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 12 0 MHz In B mode the transducer operates over a 60 mm area as a side firing probe This device is intended for use with the GlobalMed USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of endocavity etc and small organs to aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 01 9911 00 ClearProbe User Guide Revision 5 Appendix G Patient Privacy and Confidentiality There are important 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 users 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 yourself these questions What would 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
30. lobalMed USB Ultrasound Probes require special precautions to ensure electromagnetic compatibility with other electrical medical devices To ensure electromagnetic compatibility EMC GlobalMed USB Ultrasound Probes must be installed and operated according to the EMC information provided in this manual The GlobalMed USB Ultrasound Probes have been designed and tested to comply with IEC 60601 1 2 2002 requirements for EMC with other devices J CAUTION Portable and mobile RF communications equipment may affect the normal function of the GlobalMed USB Ultrasound Probes A N CAUTION Do not use cables or accessories other than those provided with the GlobalMed USB Ultrasound Probe as this may result in increased electromagnetic emissions or decrease immunity to such emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions amp Immunity GlobalMed USB Ultrasound Probes are intended for use in the electromagnetic environment specified below The customer or the user of the GlobalMed 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 Emissions EN60601 1 2 Group 1 Under Limit CISPR 11 Measure at 5 Class a meters Electrostatic Discharge EN60601 1 2 2kV 4kV 8kV 36 202 1 j EN61000 4 2 Apply to all contact discharge accessible components 2kV 4kV 8kV air discharge Radiated Immunity EN6
31. maging window will be replaced by the retrieved image data You can use the gain controls and intensity and contrast to adjust the image You can add measurements and annotations and then resave the image as a jpeg for printing Printing Jpeg images can be printed to any available Windows supported printer You can use Windows and any installed graphics program to open and print any previously saved jpeg image Navigate to the Patient Folder using the shortcut on the desktop and select the jpg file you would like to print You can also print the Image Window using the File pull down in the upper left corner of the ClearProbe application window If you have taken a patient exam you can print the exam by selecting the patient by last name in the Patent Tab and then selecting Print from the Patient control box Viewing Reference Images High resolution reference cine files are included in the Patient Data _Stat Images folder These reference images are included for you to compare to your technique and to assure you are getting optimum image quality from your system Click Load Cine file button and double click cine image file you want to view To single step through a cine loop use the arrow keys on the keyboard or scroll wheel on the mouse You can adjust intensity and contrast and perform measurements on any saved images 01 9911 00 ClearProbe User Guide Revision 5 8 Electromagnetic Compatibility Like other medical equipment G
32. n Device Statement A N 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 3 15 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 ClearProbe system software Help Menu 01 9911 00 ClearProbe User Guide Revision 5 4 General This user guide is for the Interson 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 uN WARNING Prior to patient evaluation inspect the USB Ultrasound Probe System for any physical damage such as leaking fluid and or cracked and or broken membrane housing strain relief stand by switch USB cable If physical damage exists do not use for patient evaluation and return to Interson for service evaluation 5 SeeMore Display The computer monitor screen is divided into three major sections On the left side is the Imaging Window and the Status Window The Imaging
33. ry area A N CAUTION Do not use cables or accessories other than those provided with the GlobalMed USB Ultrasound Probe as this may result in increased electromagnetic emissions or decrease immunity to such emissions CAUTION Do not store the probe in the shipping case It may become a source of infection 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 50 C 14 F to 122 F e Relative Humidity 20 to 80 no condensation e Atmospheric pressure 700 hPa to 1060 hPa 10 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 50 C 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 originally packaged in Call GlobalMed for an RMA number before returning a probe for evaluation and possible repair If the original package is not available pack in such a way that the probe is prote
34. s can damage the probe 3 8 Probe Cleaning Repetitive cleaning of the USB Ultrasound Probe System is capable of withstanding without damage or deterioration of the safety provisions the cleaning and or disinfecting process specified in this manual and the instructions for use Wear protective gloves when performing the cleaning process Disconnect the probe from the system Remove any sheaths biopsy guide adapters and biopsy needle guides Discard sheaths sheaths are a single use item in a biohazard container 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 probe s USB cable connection Wipe with a dry cloth or wipe with a water dampened cloth to remove soap residue and then wipe with a dry cloth 01 9911 00 ClearProbe User Guide Revision 5 3 9 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 biological effectiveness as qualified through the FDA 510 k process and their compatibility with GlobalMed ultrasound product materials Solutions Country Type Active ingredient FDA 510 k Cidex USA Liquid Gluteraldehyde K934434 Cidex Plus USA Liquid Gluterald
35. ssible 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 12 Disposal Contact GlobalMed Corporation before disposing of the probe 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 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 For more information concerning the return and recycling of this product please consult GlobalMed Corporation 01 9911 00 ClearProbe User Guide Revision 5 17 Appendix A ClearProbe Software Installation Do NOT plug in the USB ultrasound probe s until the software has been fully installed Software installation Plug in the Memory Stick to one of the computer s USB 2 0 ports Please open read and print the file READ ME for detailed instructions regarding installation Also print the files ClearProbe Installation pdf and XVID Installation pdf Click on the icon ClearProbeSetup x yy zz exe Follow the instructions per ClearProbe Installation pdf Per the READ ME instructions click on XVID exe Follow the instructions per XVID Installation pdf Remove the
36. stment method is to adjust all gains to the minimum left pulse power to maximum right and intensity and contrast in the middle Now increase the Near Gain until the first third of the image is just below saturation Similarly adjust the Mid Gain and finally the Far Gain Probe Select identifies all connected probes and enables you to select which probe you would like to use Only one probe can be active at a time Preset enables you to select from an included preset of ultrasound parameters A specific preset contains Intensity Contrast Near Gain Mid Gain Far Gain Frequency Depth and Power The list of available presets changes based on the probe that is selected To save a new preset type a new name over an existing preset name and select Save Settings To delete a preset select the preset name and then press delete on the keyboard Frequency allows you to select from available pulse frequencies Pulse frequencies are probe specific and as such different probes may have different pulse frequencies As image resolution is better at higher frequencies always use the highest pulse frequency that allows you to scan to your desired depth Depth changes the displayed depth range Depth ranges are dependent on the probe selected and the selected pulse frequency Scan starts and stops the scan The scan button on the probe and the keyboard s space bar will also start and stop the scan ClearProbe automatically saves the
37. transducer operates over a 29 mm area as an end firing probe This device is intended for use with the GlobalMed USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of peripheral vessels and small organs to aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 6 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 the GlobalMed 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 the GlobalMed USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of endocavity etc and small organs to aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria 01 9911 00 ClearProbe User Guide Revision 5 7 USB Transducer ER 7 5 MHz ES 7 5 MHz This device is a hand held single element mechanical sector probe intended for transcutaneous use with the GlobalMed USB ULTRASOUND PROBE SYSTEM The nominal operating frequency is 7 5 MHz In B mode the transducer operates over a 60 mm area as a Side firing probe This device is intended for use with the GlobalMed USB ULTRASOUND PROBE SYSTEM for the transcutaneous imaging of endocavity etc and small organs to aid in the detection and assessment of physical and funct
38. up to the point of immersion and then air dry or towel dry with a clean cloth 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 Draping For endocavity scanning a clean non sterile 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 01 9911 00 ClearProbe User Guide Revision 5 3 10 Surface Cleaning Refer to Probe Cleaning 3 7 page 4 3 11 Surface Disinfection Refer to Probe Disinfecting 3 8 page 4 and page 5 A N WARNING Do not immerse the probe or use heat or radiation to sterilize it This will permanently damage the probe and void the warranty 3 12 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 3 13 Electromagnetic Compatibility EMC The GlobalMed GP EC amp SP family of USB powered ultrasound probes have completed and passed EN 60601 1 2 2007 standard 3 14 Prescriptio
39. z Minimum RAM 4 GB RAM USB 2 0 port 3 Warnings Safety Information 3 1 Meaning of Signal Words In this User s 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 GlobalMed Ultrasound Probe System must understand the meanings of these signal words Signal Word Meaning Indicates a potentially hazardous situation which if not avoided could Cause injury or harm to the equipment Indicates a potentially hazardous situation which if not avoided may result in minor injury or harm to the equipment CAUTION Indicates a potentially hazardous situation which if not avoided may result in property damage Type BF Equipment 01 9911 00 ClearProbe User Guide Revision 5 3 2 Meaning of Safety Symbols Follow Operating Instructions a Attention refer to User s Manual General Cautions and Warnings A N 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 A N WARNING Do not allow sharp objects such as scalpels or cauterizing knives to touch probes or cable A N WARNING Equipment not suitable for use in the presence of flammable mixtures AN WARNING If the probe is used with other devices current leakage
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