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GE Versana Essential, Technical Publication

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Safety

4-10

Versana Essential

 – 

User Guide

5759238-100 English

 

Rev. 2

Equipment and Personnel Safety

The concerns listed below can seriously affect the safety of 
equipment and personnel during a diagnostic ultrasound 
examination.

Related Hazards 

WARNING

This equipment contains dangerous voltages that are capable 
of serious injury or death.

If any defects are observed or malfunctions occur, stop 
operating the equipment and perform the proper action for the 
patient. Inform a qualified service person and contact a Service 
Representative for information.

There are no user replaceable or serviceable components 
inside the console. Refer all servicing to GE qualified service 
personnel only.

Ensure that unauthorized personnel do not tamper with the 
unit. 

Electrical

Hazard

To avoid injury:

• 

Do not remove protective covers. No user serviceable 
parts are inside. Refer servicing to qualified service 
personnel.

• 

To assure adequate grounding, connect the attachment 
plug to a reliable (hospital grade) grounding outlet (having 
equalization conductor 

 ).

• 

Never use any adaptor or converter of a 
three-prong-to-two-prong type to connect with a mains 
power plug. The protective earth connection will loosen.

• 

Do not place liquids on or above the console. Spilled liquid 
may contact live parts and increase the risk of shock.

Summary of Contents for Versana Essential

Page 1: ...Technical Publication 5759238 100 English Rev 2 Versana Essential User Guide R1 x x Operating Documentation Copyright 2017 By General Electric Co ...

Page 2: ...is a reference for the Versana Essential ultrasound system It applies to all revisions of the R1 x x software for the Versana Essential ultrasound system GE P O Box 414 Milwaukee Wisconsin 53201 U S A Asia Pacific Latin America North America GE Ultraschall Deutschland GmbH Co KG Beethovenstrasse 239 Postfach 11 05 60 D 42655 Solingen GERMANY TEL 49 212 28 02 208 FAX 49 212 28 02 431 ...

Page 3: ...now the latest revision contact your distributor local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698 REV DATE YYYY MM DD REASON FOR CHANGE Rev 1 2017 07 18 Initial release Rev 2 2017 09 05 Update rating plate and software features CHAPTER NUMBER REVISION NUMBER CHAPTER NUMBER REVISION NUMBER Title Page Rev 2 Chapter 2 Rev 2 ...

Page 4: ...i 2 Versana Essential User Guide 5759238 100 English Rev 2 This page intentionally left blank ...

Page 5: ...nt Continuous Operation According to IEC 60529 The footswitch rate IPx8 is suitable for use in surgical rooms Probe head immersible portion and cable are IPX7 Probe connector is not waterproof This product complies with the regulatory requirement of the following Council Directive 93 42 EEC concerning medical devices the CE label affixed to the product testifies compliance to the Directive The loc...

Page 6: ...2 37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment International Organization of Standards ISO ISO 10993 1 Biological evaluation of medical devices ANSI AAMI ES60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Canadian Standards Association CSA CSA 22 2 601 1 Medical Electrical Equipment Part 1 General Requirements for Sa...

Page 7: ...759238 100 English Rev 2 Conformance Standards continued Certifications General Electric Medical Systems is ISO 9001 and ISO 13485 certified Original Documentation The original document was written in English Importer Information Turkey ...

Page 8: ...i 6 Versana Essential User Guide 5759238 100 English Rev 2 ...

Page 9: ... graphics 1 12 Peripheral Accessory Connection 1 13 Wired Footswitch Option 1 15 Control Panel Map 1 16 Top Sub Menu 1 19 Monitor Display 1 20 To adjust the Monitor Position 1 21 Adjust Monitor by Software 1 22 Moving the system Before moving the system 1 24 Wheels 1 26 Moving the System 1 28 Transporting the System 1 30 System Start Up Connecting the System 1 32 Power On 1 36 Power Off 1 38 Crash...

Page 10: ...n 2 11 Other Controls 2 12 Scan Coach Option 2 18 Scan Assistant Introduction 2 34 Scan Assistant Definitions 2 35 Scan Assistant Description 2 36 My Trainer 2 45 Overview 2 45 SonoBiometry AFB SonoBiometry AFB 2 49 Measurement and Analysis Introduction 2 53 Location of Measurement Controls 2 54 B Mode Measurements 2 55 Doppler Mode Measurements 2 62 M Mode Measurements 2 66 Wide Dual Screen Measu...

Page 11: ...ation Contacting GE Ultrasound 3 62 Manufacturer 3 68 Chapter 4 Safety Owner Responsibility Owner requirements 4 2 Safety Precautions Precaution Levels 4 3 Hazard Symbols 4 4 Patient Safety 4 6 Equipment and Personnel Safety 4 10 Material Safe Data 4 16 Use of ECG 4 16 Electrical safety 4 17 EMC Electromagnetic Compatibility 4 18 Minimum distances 4 28 Basic Safety 4 29 Essential performance 4 29 ...

Page 12: ...oduction 5 20 Application 5 21 Features 5 22 Specifications 5 23 Slice Thickness Specification 5 23 Probe Illustration 5 24 Biopsy Special Concerns Precautions Concerning the Use of Biopsy Procedures 5 26 Preparing for a Biopsy Displaying the Guidezone 5 28 Preparing the Biopsy Guide Attachment 5 31 Biopsy Needle Path Verification 5 40 The Biopsy Procedure 5 41 Post Biopsy 5 42 Surgery Intra opera...

Page 13: ...Versana Essential User Guide 1 1 5759238 100 English Rev 2 Chapter 1 Getting Started Console Overview Moving the System System Start up Probes and Beginning an Exam ...

Page 14: ...re difference between Online Help and Basic User Manual User Guide please refer to Basic User Manual User Guide for the only right version Disregarding information on safety is considered abnormal use Not all features products probes or peripherals described in this document may be available or cleared for sale in all markets Please contact your local GE Ultrasound representative to get the latest...

Page 15: ...basic ultrasound principles and techniques They do not include sonographic training or detailed clinical procedures NOTE The system color varies NOTE The electronic documentation CD includes English and all translations NOTE The screen graphics in this manual are only for illustrational purposes Actual screen output may differ with the different software version ...

Page 16: ...ing filters with many frequency and time response options transforming the high frequency electrical signals into a series of digital image signals which are stored in memory Once in memory the image can be displayed in real time on the image monitor All signal transmission reception and processing characteristics are controlled by the main computer By selection from the system control panel the u...

Page 17: ...tem is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye Prescription Device CAUTION United States law restricts this device to sale or use by or on the order of a physician Intended Use The Versana Essential is intended for use by a qualified physician for ultrasound evaluation ...

Page 18: ...ascular Adult Cephalic Pediatric Musculoskeletal Transcranial Neonatal Cephalic Transvaginal Urological and Cardiac Transrectal imaging guidance of interventional procedure and biopsy Frequency of use Daily Typically 8 hours Operator profile Qualified and trained physicians or sonographers with at least basic ultrasound knowledge The operator must have read and understood the user manual NOTE Only...

Page 19: ...Gynecological Small parts Vascular Peripheral Vascular Transcranial Pediatric Neonatal Musculoskeletal Urological Cardiac Transvaginal Transrectal Biopsy Image Acquisition is for diagnostic purposes including measurements on acquired image CAUTION This machine should be used in compliance with law Some jurisdictions restrict certain uses such as gender determination ...

Page 20: ...or more information The Versana Essential does not contain any operator serviceable internal components Ensure that unauthorized personnel do not tamper with the unit Perform regular preventive maintenance See System Care and Maintenance on page 3 30 for more information Maintain a clean environment Turn off and if possible disconnect the system before cleaning the unit See Cleaning the system on ...

Page 21: ... cause some electronic interference to radios and televisions around the equipment Ensure that the following is provided for the new system Take precautions to ensure that the console is protected from electromagnetic interference Precautions include Operate the console at least 15 feet away from motors typewriters elevators and other sources of strong electromagnetic radiation Operation in an enc...

Page 22: ...e with regard to fan speed Ensure adequate system room ventilation Table 1 1 System Environmental Requirements Operational with probe Storage Versana Essential Transport Versana Essential Temperature 10 40 C 50 104 F 5 50 C 23 122 F 5 50 C 23 122 F Humidity 30 80 non condensing 10 90 non condensing 10 90 non condensing Pressure 700 1060hPa 700 1060hPa 700 1060hPa CAUTION The system cannot be used ...

Page 23: ...e that there is sufficient air flow around the ultrasound unit when installed in a fixed location CAUTION Do not cover the ventilation holes of the Versana Essential CAUTION The Versana Essential system and probe connector are not waterproof Do not expose the device to water or any kind of liquid ...

Page 24: ...ions of the console Figure 1 1 Versana Essential System an example NOTE USB Port 6 is only for memory disk not available for other peripheral 1 Monitor 2 Speaker 3 Control Panel 4 Probe Connector 5 Wheel 6 USB Port 7 Probe Holder 8 Printer Box 9 Rear Panel 10 Rear Handle 11 Gel Bottle Holder 12 Body Left and Right Cover ...

Page 25: ...ION The connection of equipment or transmission networks other than as specified in these instructions can result in electric shock hazard Alternate connections will require verification of compatibility and conformity to IEC EN 60601 1 by the installer CAUTION DO NOT touch the patient and any of the connectors on the ultrasound unit simultaneously including ultrasound probe connectors DO NOT touc...

Page 26: ...ry Connector Panel 1 S Video S Video Out 2 HDMI port For video port 3 VGA VGA Video Out 4 Ethernet 100MBase T for net connectivity 5 Dual USB port USB for use 6 Composite Out Composited Video Out 7 AC Inlet 100 240V 8 Circuit breaker Circuit breaker 9 Diagnostic LED 1 For diagnostic 10 Diagnostic LED 2 For diagnostic 11 Diagnostic LED 3 For diagnostic ...

Page 27: ... Pedal Type Footswitch You can configure the function of Footswitch from the Utility Application Settings Footswitch CAUTION To avoid damage of the cable keep the cable away from the wheels Disconnect the Footswitch before moving the system CAUTION When using the Footswitch DO NOT hold down the footswitch pedal Press and release the Footswitch pedal Pushing and holding down the pedal behaves the s...

Page 28: ...1 Power On Off 2 Menu keys 3 Up Down keys 4 TGC 5 User Configurable keys 6 Patient key 7 Probe key 8 Report key 9 End Exam key 10 Whizz key Auto Optimize 11 M Mode M Mode Gain 12 CW Option 13 PW Mode PW Gain 14 PDI 15 CF Mode CF Gain 16 B Mode B Mode Gain 17 Depth 18 Ellipse Zoom key 19 Scan Coach 20 Left Right key 21 Print key 22 Freeze key 23 Store key 24 Cursor key 25 Clear key 26 Measure key 2...

Page 29: ...Overview Versana Essential User Guide 1 17 5759238 100 English Rev 2 Alphanumeric Keyboard Figure 1 6 Alphanumeric Keyboard ...

Page 30: ...Move annotation cursor to home position shift key to set current annotation cursor position as the new home position Text1 Text2 F8 Key Switch between user text annotation overlays Grab Last F9 Key Activate the last selected data for edit Word Delete F10 Key Erase word associated with comment cursor Fn Left Right Keys Adjust audio volume Fn Up Down Arrow Keys Adjust brightness Alt 1 or Alt 2 Place...

Page 31: ...ob clockwise or anticlockwise the paddle switches are used to access and adjust the menu The functionality of these controls change depending upon the currently displayed menu The below figure displays five Primary menu functions at the bottom of the image Per page only five primary menu functions are displayed To navigate and view the 15 primary menu functions use the Up Down key to move to the n...

Page 32: ...een 8 Delete Image 9 Save As Menu 10 Three types of Images Clipboard 11 Primary Menu Page Indication 12 Trackball Functionality Status 13 Current date and time Caps Lock lit when on network connection indicator system messages display InSite status InSite controls 14 Image Preview 15 Measurement Summary Window 16 Exam Category 17 Probe Orientation Marker 18 Image 19 Region of interest 20 Gray Colo...

Page 33: ... of the monitor when you adjust the position of the monitor Figure 1 10 Grab the bottom of the monitor CAUTION When flipping up the monitor from the flip down status you can grab the upper corner of the monitor CAUTION To avoid injury or damage make sure nothing is within the range of motion before moving the monitor This includes both objects and people ...

Page 34: ...he Color Temperature Contrast Brightness and LCD To adjust the color temperature press Standard Brown or Blue to choose the color temperature The chosen color temperature displays in the Color Temp area Figure 1 12 Color Temperature To adjust the Contrast Press Set to choose the adjustment button hold down the Set key and move the trackball to move the adjustment button Move the adjustment button ...

Page 35: ...crease the brightness Figure 1 14 Brightness To adjust the LCD at the bottom of the Monitor Press Set to choose the adjustment button hold down the Set key and move the trackball to move the adjustment button Move the adjustment button to the left to decrease the LCD brightness or move the adjustment button to the right to increase the LCD brightness Figure 1 15 LCD Brightness 3 Press Reset to ret...

Page 36: ...the system is not in use AND OR before moving transporting the system make sure the monitor is flipped down to prevent system damage CAUTION DO NOT place probes or the footswitch into the side tray when moving transporting the system It is not storage space for probes footswitch and any peripheral devices CAUTION This equipment is not to be used during transportation e g ambulance cars aircraft CA...

Page 37: ...eral devices and the ethernet connection must be disconnected from the console 5 Ensure that no loose items are left on the console 6 Connect all probes to be used while off site Ensure that probe cables are out of the way from the wheels and not protruding beyond the console Use the probe management hooks located below the Control Panel to further secure the probe cables 7 Store all other probes ...

Page 38: ...ntly for any obvious defects that could cause them to break or bind All the four wheels have independent brake pedals Figure 1 16 Wheel lock 1 Locked Press on the brakes to block the caster wheels 2 Unlocked Release the brakes to unlock the caster wheels Moving Hazard Never move the system with locked wheels ...

Page 39: ...inued CAUTION When two or more people are releasing the wheel controls with the front and rear wheels take extra precaution to prevent unexpected movement which could result in possible toe injuries CAUTION If you use park the system on a slippery slope you MUST use the brakes on the wheel ...

Page 40: ...ive degrees 3 Use the foot brake pedal located on the bottom of the system in the front when necessary 4 Do not let the system strike walls or door frames 5 Use extra care when crossing door or elevator thresholds 6 Once the destination is reached lock the wheels Moving the system no incline Moving the system on incline CAUTION DO NOT attempt to move the console using any cables or fixtures such a...

Page 41: ... 1 29 5759238 100 English Rev 2 Moving the system continued CAUTION DO NOT attempt to move the system with the monitor by pulling cables or belts placed around the monitor and or monitor arm Do not put your whole body weight on the foot rest holder ...

Page 42: ...or more information In addition to the instructions used when moving the system also perform the following 1 Before transporting place the system in its special storage case 2 Ensure that the system is firmly secured while inside the vehicle 3 Secure the system with straps or as directed otherwise to prevent motion during transport CAUTION Remove all peripherals from the console before transportat...

Page 43: ...g order 6 Secure the system while it is on the lift so that it cannot roll Use either wood chocks restraining straps or other similar types of constraints Do not attempt to hold it in place by hand 7 Employ two or three persons to load and unload safely from a vehicle 8 Load the unit aboard the vehicle carefully and over its center of gravity Keep the unit still and upright NOTE Do not lay the uni...

Page 44: ...s not pulled out of the wall if the system is moved slightly 4 Attach the power plug to the system and then install the power cable bracket a Ensure the power plug is placed securely in power cable bracket Figure 1 17 Circuit Breaker and Power Plug 5 Push the power plug securely into the wall outlet NOTE Do not use an extension cord or adapter plug 6 Switch ON the Circuit Breaker b The On Off butt...

Page 45: ...dequate earth circuit can cause electrical shock resulting in serious injury Connection of additional protective earth conductors or potential equalization conductors is not necessary in most cases and is only recommended for situations involving multiple equipment in a high risk patient environment to provide assurance that all equipment is at the same potential and operates within acceptable lea...

Page 46: ...United Kingdom the United States Israel and Australia Voltage level check Check the rating label on the rear side of the system Check the voltage range indicated on the label Connecting to the electrical outlet WARNING POWER OUTAGE MAY OCCUR The ultrasound unit requires a dedicated single branch circuit To avoid circuit overload and possible loss of critical care equipment make sure you DO NOT hav...

Page 47: ...verload If a power overload occurs 1 Turn off all peripheral devices 2 Reactivate the Circuit Breaker switch Figure 1 19 Circuit Breaker located on the rear panel The Circuit Breaker switch should stay in the On position DO NOT hold the switch in the On position If the Circuit Breaker switch remains On follow the Power On procedure 1 On position 2 Off position NOTE If the Circuit Breaker switch do...

Page 48: ... the Power On Off switch illumination turns to blue After a successful boot up process the Power On Off switch illumination turns from blue to green the keyboard backlight is lit CAUTION Press the Power On Off switch to turn the power on The circuit breaker must also be in the on position For circuit breaker location See Circuit breaker on page 1 35 for more information ...

Page 49: ...mpted to login Figure 1 20 Operator Login Window 1 Operator Select the Operator 2 Password Enter Operator s password optional 3 Select type of Logon or Cancel OK Standard logon Cancel Cancel logon NOTE When you login as administrator for the first time you are prompted to set a password NOTE A valid password must be at least 6 characters A password must contain at least 1 upper case 1 lower case a...

Page 50: ...h illumination turns from green to blue NOTE DO NOT select Exit for Shutdown Exit is only available to Service representative NOTE If the system has not fully shut down in 60 seconds in the power off sequence press and hold down the On Off switch until the system shuts down 3 Disconnect the probes Clean or disinfect all probes as necessary Store them in their shipping cases or another appropriate ...

Page 51: ...ends the current exam and permanently store all the images and measurements When the system reboots check that all images and measurements have been preserved in the system Then simply hold down the power switch to initiate a normal power down sequence NOTE If the image is not updated properly when the system is up shut down the system again NOTE Generic reports are not saved if the system crashes...

Page 52: ...and connector DO NOT use a transducer which appears damaged until functional and safe performance is verified A thorough inspection should be conducted during the cleaning process CAUTION Remove any dust or foam rests from the probe pins CAUTION Fault conditions can result in electric shock hazard Do not touch the surface of probe connectors which are exposed when the probe is removed DO NOT touch...

Page 53: ...e probe s carrying case on a stable surface and open the case 2 Carefully remove the probe and unwrap the probe cord 3 Put the probe in the probe holder 4 Hold the probe connector horizontally with the cable pointing upward 5 Slide the connector lock to the left unlocked position Figure 1 21 Unlocked position CAUTION DO NOT allow the probe head to hang free Impact to the probe head could result in...

Page 54: ...or into the probe port and slide the connector lock to the right position to lock the probe connector Figure 1 22 Lock the probe connection 7 Wrap the probe cables around the probe cable hooks under the control panel Ensure the probe cables are wrapped properly not extended beyond sides of console Figure 1 23 Handle probe cable ...

Page 55: ...o freeze mode The probe s default settings for the mode and selected exam are used automatically Disconnecting the Probe Probes can be disconnected at any time However the probe should not be active when disconnecting the probe 1 Deactivate the probe 2 Slide the connector lock to the left position to unlock the probe 3 Pull the probe connector straight out of the probe port carefully 4 Ensure the ...

Page 56: ...9238 100 English Rev 2 Beginning an Exam Patient Screen Figure 1 24 Patient Screen 1 Image Management 2 Function Selection 3 EZBackup EZMove 4 Dataflow Selection 5 Scan 6 Patient Information 7 Category Selection 8 Exam Information 9 Patient View Exam View ...

Page 57: ...fication with the patient Make sure the correct patient identification appears on all screens and hard copy prints WARNING Always use the minimum power required to obtain acceptable images in accordance with applicable guidelines and policies WARNING Always use the system on a flat surface in the patient environment WARNING Ensure that the hands of the patient are away from the system during the e...

Page 58: ... when the patient is registered to No Archive If the Warn register to No Archive preset is selected in the Utility Connectivity Miscellaneous menu a warning displays Please select a different dataflow for permanent storage of patient data 5 Fill in patient information NOTE You can also select a patient from the patient database at the bottom of the Patient menu if the patient has a patient ID NOTE...

Page 59: ...re the cineloop press Freeze and run the cineloop using the Trackball Select the start end frame and run the selected loop Press Store 10 When you have completed the study press End Exam The Active Images screen displays Select the images still frame or cineloop you want to store or simply select Permanent Store to store the images permanently CAUTION After completing the measurement verify that t...

Page 60: ...as not saved 4 Enter the Patient ID 5 Enter the patient and exam information 6 Press Register 7 Repeat above steps as required Select the patient from the Patient List Select Resume Exam to continue the last exam that was performed on the selected patient Select New Exam to start a new exam on the selected patient Starting a new exam on an existing patient 1 Select Patient on the control panel 2 S...

Page 61: ...scanning is finished press Patient to display the Patient Search screen 3 Enter the Patient ID patient data and exam information as necessary select Register 4 If images or measurements have been stored to the clipboard the system will display the following message Unsaved images measurements or fetus number will be linked to the current patient information continue Press OK if you want to permane...

Page 62: ...patient list the following dialog displays Figure 1 25 Unsaved Exam Data 1 Store All All the unsaved images will be saved to the current patient 2 Review Images Review the unsaved images in Active Images page and select to permanent store or delete 3 Delete All Delete all the unsaved images The system will display a dialog Do you really want to delete all temporary images Select OK to delete the u...

Page 63: ...ved Exam Data 1 Store All All the unsaved images will be saved The current patient doesn t have Patient ID the system will indicate to enter patient ID Figure 1 27 Enter Patient ID Input manually Input the Patient ID and other information manually and then select Register to register the new patient And the system will display Unsaved images measurements or fetus number will be linked to the curre...

Page 64: ...ges Review the unsaved images in Active Images page and select to permanent store or delete 3 Delete All Delete all the unsaved images The system will display a dialog Do you really want to delete all temporary images Select OK to delete the unsave iamges select Cancel not to delete the images 4 Cancel Do nothing with the unsaved data and return to Patient page ...

Page 65: ... and selecting patients one by one or holding down the Shift key to select a group of patients 2 Select Delete The confirmation dialog box displays OR Press the Cursor key A pop up menu displays Select Delete The confirmation dialog box displays 3 Select OK to delete or Cancel Delete the existing exam 1 Search and select the patient in the patient list under patient screen 2 Select Exam View to di...

Page 66: ...atient in the patient list under patient screen 2 Select Exam View The patient exam screen displays 3 Select the exam which contains the image to be deleted 4 Select Active Images to display the image list 5 Select the image to delete and select Delete The confirmation dialog box displays 6 Select Yes to delete or No to cancel ...

Page 67: ...Versana Essential User Guide 2 1 5759238 100 English Rev 2 Chapter 2 Performing an Exam Optimizing the Image Measurement and Analysis ...

Page 68: ...responding to the focal zone position s appears on the right edge of the image Whizz No Whizz will continuously optimize the brightness contrast and uniformity of B mode images when scanning on different tissues Whizz in PW CW Doppler Mode ASO Auto Spectral Optimization optimizes the spectral data Auto adjusts the Velocity Scale PRF live imaging only baseline shift and invert if preset Upon deacti...

Page 69: ...ties are converted to shades of gray thereby increasing the adjustable range of contrast Line Density Yes Optimizes B Mode frame rate or spatial resolution for the best possible image Gray Map No The system supplies B M and Doppler Mode system maps Frame Average No Temporal filter that averages frames together thereby using more pixels to make up one image This has the effect of presenting a smoot...

Page 70: ...OGIQ View Option No LOGIQ View provides the ability to construct and view a static 2D image which is wider than the field of view of a given transducer This feature allows viewing and measurements of anatomy that is larger than what would fit in a single image Examples include scanning of vascular structures and connective tissues in the arms and legs LOGIQ View constructs the extended image from ...

Page 71: ...ccurring over time along a single vector Table 2 2 M Mode Controls Control Bioeffect Description Benefit Sweep Speed No Changes the speed at which the timeline is swept Available in M Mode Doppler Mode and M Color Flow Mode Anatomical M Mode option Yes Anatomical M Mode gives you the ability to manipulate the cursor at different angles and positions The M Mode display changes according to a motion...

Page 72: ...oward positive velocities You can invert a real time or frozen image NOTE Invert reverses the color map NOT the color PRF Baseline No Changes the Color Flow or Doppler spectrum baseline to accommodate higher velocity blood flow Minimizes aliasing by displaying a greater range of forward flow with respect to reverse flow or vice versa Baseline adjusts the alias point The default baseline is at the ...

Page 73: ...he tissue rather than the frequency shift of the signal Using this technique the ultrasound system plots color flow based on the number of reflectors that are moving regardless of their velocity PDI does not map velocity therefore it is not subject to aliasing TVI Option Yes Tissue Velocity Imaging TVI calculates and color codes the velocities in tissue The tissue velocity information is acquired ...

Page 74: ... M Color Flow Mode M Color Flow is used for cardiac applications Color Flow overlays color on the M Mode image using velocity and variance color maps The Color Flow wedge overlays the B Mode image and M Mode time line See Color Flow Mode Controls on page 2 6 for more information ...

Page 75: ...e velocity scale to accommodate faster slower blood flow velocities Velocity scale determines pulse repetition frequency If the sample volume gate range exceeds single gate Scale capability the system automatically switches to high PRF mode Multiple gates appear and HPRF is indicated on the display Angle Correct No Estimates the flow velocity in a direction at an angle to the Doppler vector by com...

Page 76: ...ions are automatically calculated Auto Calcs No Activates the calculation automatically which you select in the Modify Auto Calculation when the system is in a state of freeze or live Simultaneous Duplex Triplex Yes When you select Simultaneous everything is live Simultaneous includes duplex and triplex For example it is duplex if both B Mode and PW Doppler Modes are active it is triplex if B Mode...

Page 77: ...an evenly To perform a sweep fan scan rock the probe once Note the distance of the scan 5 The 3D volume of interest VOI is dynamically assembled on the right side of the screen NOTE If the image stops before you re done scanning start acquiring the 3D volume of interest again 6 To complete the 3D scan press R the right split screen key NOTE You can also press Freeze but then you need to also press...

Page 78: ...y To exit zoom press B Mode or rotate Zoom counterclockwise until the reference zoom image is removed Reference Image is the small un zoomed image displayed next to the zoomed image Read Zoom To activate Read Zoom turn the Zoom knob Read Zoom magnifies the display of the data without making any changes to the ultrasound image data that is acquired Available in a live frozen cine or recalled raw da...

Page 79: ...Zoom the Ultrasound line density and or sampling frequency increases giving a better resolution Available only in pre processing You can preset the write zoom window size height and width on Utility Imaging B Mode NOTE The difference between Read Zoom and Write Zoom can be described in relation to photography With a photograph Read Zoom manipulates the negative and enlarges the picture whereas Wri...

Page 80: ... L R To deactivate press R until the screen changes NOTE To put a copy of the image on the opposite side when entering dual split screen use the When Entering Dual Image preset found on Utility Application Settings preset page Simultaneous mode While using CFM or PDI press the L and R keys simultaneously to display B and B CFM or B and B PDI in real time on the left and right side It is useful to ...

Page 81: ...both images freeze immediately Deactivating Freeze restarts both modes To reactivate the image Press Freeze again The Freeze key backlight becomes blue unfreeze Image is on real time scan mode Live image NOTE Deactivating Freeze erases all measurements and calculations from the display but not from the report Use the Trackball to start CINE after pressing Freeze Activating CINE To activate CINE 1 ...

Page 82: ...play format is changed NOTE Body Pattern Position is reset to factory default when patient is changed e g End Exam A probe mark is associated with the body patterns and illustrates the probe position on the body pattern This marker can be placed with the Trackball and rotated with the Body Pattern button The probe mark type is selectable by rotating the Probe Type control There are different choic...

Page 83: ...phanumeric keyboard After activating the comment mode a vertical bar type cursor appears on the screen Use the Trackball to move the cursor To delete comments by character press the Backspace key To delete all comments and arrow marks press the Clear key after entering the comment mode To move by words or by text group press the Tab key Arrow pointers can be used by activating the Arrow key on the...

Page 84: ...CEIVED EDUCATION AND TRAINING Scan Coach IS AN ON DEMAND REFRESHER AND REMINDER TOOL WHICH DISPLAYS INFORMATION IN THE FORM OF DICOM IMAGES AND ANIMATIONS THE PROVIDED REFERENCE MATERIAL MAY HELP USER IN ACQUIRING ULTRASOUND IMAGES Scan Coach DOES NOT PROVIDE A DIAGNOSIS BUT DOES PROVIDE REFERENCE MATERIAL FOR SOME TYPES OF ACQUISITIONS Scan Coach IS MEANT TO PROVIDE REFERENCE MATERIAL FOR ACQUISI...

Page 85: ...ARTS ANATOMICAL MEASUREMENTS AND CLINICAL DIAGNOSIS LIES WITH YOU THE ULTRASOUND USER TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW GE AND ITS AFFILIATES DISCLAIM ALL LIABILTY AND RESPONSIBILITY FOR ANY DAMAGES SUFFERED BY A USER OR PATIENT OF A USER INCLUDING BUT NOT LIMITED TO DAMAGES ARISING OUT OF LOSS OR INACCURACY OF CONTENT OF Scan Coach IT IS THE RESPONSIBILTY OF YOU THE ULT...

Page 86: ...advances to the next step in an exam annotates the image initiates measurements and assigns the measurements to the report Scan Coach is based on Scan Assistant it displays information which helps user acquire the right scan plane The reference image indicates how the scan plane image for a given step should look like The probe beam anime image shows the corresponding probe placement or beam forma...

Page 87: ...can Coach Display Description 1 Program step number and step name NOTE The user is also able to select the program step by pressing the Up Down key on the AN keyboard 2 Select this icon to activate Reference image 3 Select this icon to activate Animation and Reference image 4 Select to Restart Exit or Edit Scan Coach ...

Page 88: ...m 2 22 Versana Essential User Guide 5759238 100 English Rev 2 Setting up Scan Coach Go to Utility Scan Coach Scan Coach Manager to create import export and manage the Scan Coach programs Figure 2 2 Setting up scan coach ...

Page 89: ...2 23 5759238 100 English Rev 2 Using Scan Coach 1 Go to Utility Scan Coach Scan Coach Manager select the protocol from the left column move it to the Program Selections column Then select Exit to the Scanning page Figure 2 3 Select Scan Coach Protocol ...

Page 90: ...mation Select Acknowledge to continue Figure 2 4 Scan Coach Addendum Or select Cancel not to start Scan Coach Check the box before Don t show next time and the Scan Coach addendum won t display next time 3 Select the protocol from the pull down menu and then select Start NOTE If there is only one program in the current application the system will display the Scan Coach screen directly This step is...

Page 91: ...ys Use Protocol Preview is selected in Utility System General the system will display a demo for the programs It helps the user understand the workflow of Scan Coach NOTE Uncheck Always Use Protocol Preview and the system will not show the program preview Figure 2 6 Utility System General Figure 2 7 Scan Coach Preview ...

Page 92: ...Exam 2 26 Versana Essential User Guide 5759238 100 English Rev 2 Using Scan Coach continued 5 Select program for example LIVER LENGTH then select the button 1 to review the reference image Figure 2 8 Using Scan Coach ...

Page 93: ...7 5759238 100 English Rev 2 Using Scan Coach continued 6 The reference image is displayed Then select the button 2 to view the probe position and schema also You can also press the button 1 to return to the program step list Figure 2 9 Using Scan Coach L1 ...

Page 94: ...s reference image probe position and schema to guide the user acquire the right scan plane Select the button marked as 1 to stop restart the video that demonstrates the probe position Figure 2 10 Using Scan Coach L2 a live scan image b reference image c probe position d two dimensional schema of the current scan plane ...

Page 95: ... Image Versana Essential User Guide 2 29 5759238 100 English Rev 2 Edit Scan Coach Protocol 1 To edit Scan Coach protocols go to Utility Scan Coach Scan Coach Manager and select Creator Figure 2 11 Scan Coach Manager ...

Page 96: ...User Guide 5759238 100 English Rev 2 Edit Scan Coach Protocol continued Or Select the button marked as 4 in the program list Figure 2 12 Program List Then select and the system will lead to the Scan Coach Edit page Figure 2 13 Edit the Protocol ...

Page 97: ...nued 2 The Scan Coach Creator is used to build customized programs that can be imported onto the Versana Essential Select Scan Coach on the tool bar to display the Scan Coach edit page Figure 2 14 Scan Coach Creator 3 Select the Scan Plane Select Browse to upload the reference image Figure 2 15 Select Scan Plane ...

Page 98: ...it Scan Coach Protocol continued 4 Select Upload to Upload the reference image from the folder called Reference Images of the corresponding application Then select Close after the upload is complete NOTE The reference image only supports dcm file Figure 2 16 Upload Reference Image 1 ...

Page 99: ... the appropriate image to upload Figure 2 17 Upload Reference Image 2 5 Upload Probe Position Image and Schema Image from the folder called Other Images of the corresponding application or from the external devices NOTE A protocol can be created without uploading the reference image but the protocol without reference image do not display in Utility Scan Coach Scan Coach Manager It can be found via...

Page 100: ...CW Doppler Dual on Freeze Depth Color Scale PW Doppler Scale PW Sample Volume size and Flow Model Selection You can initiate one or more manual Doppler measurements calculations Body Patterns are available for use during a Scan Assistant program You can turn a Body Pattern on off select a particular Body Pattern graphic and specify the position of the probe mark on the Body Pattern graphic The foo...

Page 101: ...can Assistant page to import export Programs created via the Scan Assistant Creator and to assign Programs to a user exam category Import Used to load Programs created via the Scan Assistant Creator on to the Versana Essential Export Used to move Programs from one Versana Essential system to another Versana Essential Scan Assistant Creator Used to create Scan Assistant Programs ...

Page 102: ...am step status Complete Incomplete step number step name A checkmark indicates that this step has been completed You can also manually check the box to bypass this step 4 This column indicates that the action moves the Program to the next step 5 Active step 6 This column indicates the mode or when a measurement needs to be made 7 Edit Pencil Icon 8 Stop Stop also allows the program to be stopped r...

Page 103: ...tor or exported from another Versana Essential program a Insert the media with the saved Program from the Scan Assistant Creator or exported program from another Versana Essential b Press Utility Scan Assistant c Select Import from the Scan Assistant Manager page Figure 2 19 Import Programs d In the Source field at the top of the Import Programs pop up select the media that the Program is stored o...

Page 104: ... Versana Essential User Guide 5759238 100 English Rev 2 Setting up Scan Assistant continued e Select the Program s to be imported If a folder is selected all programs in the folder will be imported Figure 2 20 Import Programs ...

Page 105: ...uide 2 39 5759238 100 English Rev 2 Setting up Scan Assistant continued f Select Import The Program s you selected are stored to the Versana Essential Select Exit Then you can add it to the exam category and user Figure 2 21 Import Completed ...

Page 106: ...m Category and User for this Program You can select All Users or a specific user If you specify All Users all users will have the ability to use this Program while in the specified exam category unless the user has his her own list defined 3 Select the imported Program from Available Programs Custom Programs on the left hand side of the page Then press the right arrow button to move the imported P...

Page 107: ...sistant Creator from the image screen make edits and then run Scan Assistant to test your changes NOTE If you edit the program after you have already stored several images and your edits change the number of program steps you are prompted to Restart or Continue the Scan Assistant program NOTE If you edit the program after you have already completed several steps checkmarked steps remain checkmarke...

Page 108: ... Scan Assistant the Program is active when you exit the Patient menu The Program is located on the left hand side of the display and as you can see in the example below the annotation for the first step has been automatically noted on the image ready for you to scan the specified anatomy Figure 2 23 Scan Assistant Display ...

Page 109: ...nt You can map Pause Resume Previous Step and Next Step to the footswitch 3 To pause or unpause Scan Assistant press the pause button on the display 4 To stop or restart a Program press the Stop icon at the bottom of the Scan Assistant Program A dialog pops up This dialog lets you restart the current Program start another Program or stop Scan Assistant 5 To skip a step or move to a certain step pr...

Page 110: ...age 4 In the Source field at the top of the Export Programs pop up select the media that the Program is to be stored on 5 Specify the Program Directory using the drop down menu if the desired Program Directory already exists on the media If not or if you want to export the Program to a new Program Directory type a new Program Directory name in the field 6 Select the Program s to be exported If a f...

Page 111: ...iner provides a quick guide to operate the system To access My Trainer 1 Press Alt H to enter My Trainer Or Press Utility System User Configurable Key Check Enable Numeric Key then set My Trainer in the Keyboard Key or User Defined Key Figure 2 25 Set My Trainer 2 Press defined key to access My Trainer ...

Page 112: ... up Date time set up Enable options check Language setting User conf User preset 3 Peripheral Connection Back panel ports Network Connectivity Connect to a printer DICOM setting Back up restore the patient information software version 4 Maintenance Trackball Contact GE service Connect to Insite Log export Air Filter Replacement 5 Quick Card Control Panel Overview Entering Patient Data Selecting a ...

Page 113: ... the section to show the list of subsections 3 Subsections 4 The highlighted subsection shows this subsection is currently opened and displayed on the right side 5 Exit Press this button to exit this interface 6 The left number shows the current page of the subsection The right number shows the total pages of the subsection 7 Illustration with graphic 8 Text instruction about how to operate Table ...

Page 114: ... an Exam 2 48 Versana Essential User Guide 5759238 100 English Rev 2 Select the arrow to move to the next page Select the arrow to go to the home page Select the arrow to go to the end page Table 2 6 Page turning ...

Page 115: ...firmed by the user or can be changed manually Table 2 7 List of Abbreviations Abbreviation Full Form Definition AC Abdominal Circumference Abdominal Circumference of the baby s abdomen BPD Biparietal Diameter Transverse distance between the protuberances of the two parietal bones of the skull FL Femur Length The length in centimeters of the developing baby s femur the femur is the long bone in the...

Page 116: ...lish Rev 2 SonoBiometry AFB continued Using SonoBiometry AFB 1 Press Utility and then select System 2 Select System Measure 3 Check the desired boxes under SonoBiometry AFB Option Selection to enable system suggested measurements Figure 2 28 SonoBiometry AFB checkboxes ...

Page 117: ... Guide 2 51 5759238 100 English Rev 2 Using SonoBiometry AFB Select OB Press Measure Select BPD HC AC FL Figure 2 29 SonoBiometry AFB option NOTE SonoBiometry AFB measurements are supported on only recalled raw DICOM images and frozen images ...

Page 118: ...ews an SonoBiometry AFB measurement will change to manual measurement automatically Zoomed image Rotated image NOTE If a particular scanned image does not have valid fetus data a warning message appears Auto measurement failure Adjust calipers manually NOTE If a particular image is not supported for SonoBiometry AFB measurement a warning message appears Auto measurements do not operate on DICOM im...

Page 119: ...atabases used within the system software that are associated with specific investigators are so noted Be sure to refer to the original article describing the investigator s recommended clinical procedures WARNING The system provides calculations e g estimated fetal weight and charts based on published scientific literature The selection of the appropriate chart and clinical interpretation of calcu...

Page 120: ...nd the calculation package associated with the currently selected preset 3 Zoom Ellipse To Zoom an image rotate Zoom clockwise After the first caliper for a distance measurement has been set and the second caliper positioned Ellipse activates the area ellipse measurement function During the ellipse adjustment use the Trackball to increase or decrease the size of the ellipse Select Cursor Select to...

Page 121: ...English Rev 2 B Mode Measurements Two basic measurements can be made in B Mode Distance Circumference and Area Ellipse Method Trace Method Spline Method Intensity Echo level Method NOTE The following instructions assume that you first scan the patient and then press Freeze ...

Page 122: ...rackball A dotted line connects the measurement points if preset accordingly 5 To complete the measurement press Set The system displays the distance value in the Results Window HINTS Before you complete a measurement To toggle between active calipers adjust Cursor Select To erase the second caliper and the current data measured and start the measurement again press Clear once After you complete t...

Page 123: ...djust the Ellipse control an ellipse with an initial circle shape displays 6 To position the ellipse and to size the measured axes move the calipers move the Trackball 7 To increase or decrease the Ellipse adjust the Gain control on the Trackball 8 To toggle between active calipers adjust Cursor Select 9 To complete the measurement press Set The system displays the circumference and area in the Re...

Page 124: ...Open Trace To trace the circumference of a portion of the anatomy and calculate its length 1 Press the Measure key in Measure mode to select Trace an active caliper displays 2 To position the caliper at the start point move the Trackball 3 To fix the trace start point press Set The caliper changes to an active caliper 4 To trace the measurement area move the Trackball around the anatomy A dotted l...

Page 125: ...irst caliper is activated If Clear is pressed again the first caliper disappears and the Spline trace is cancelled 4 To position the second caliper move the Trackball and press Set The third caliper appears at the same position NOTE The Clear key functionality is the same as noted in the previous step The spline trace requires at least three points to draw the trace Continue setting the points of ...

Page 126: ...ts including the pick caliper are removed If the previous next fixed caliper exists on the image it is activated NOTE Pressing Clear at this time removes all points and the trace graphic 2 Move the pick caliper to the desired point and press Set The point is activated and turns green 3 Move the point to the desired position and press Set The point is fixed and turns yellow The pick caliper appears...

Page 127: ...s Set The caliper changes to an active caliper 4 To trace the measurement area move the Trackball around the anatomy A dotted line shows the traced area 5 To complete the measurement press Set The system displays the echo level as EL __ dB in the Results Window NOTE The echo level measurement is only available on a frozen image not on a B paused image NOTE Echo Level is not available through the f...

Page 128: ...ume Flow NOTE The following instructions assume that you do the following 1 In the B Mode part of the display scan the anatomy you want to measure 2 Go to the Doppler Mode part of the display 3 Press Freeze Velocity To measure velocity 1 Press Measure an active caliper with a vertical dotted line displays 2 To position the caliper at the desired measurement point move the Trackball 3 To complete t...

Page 129: ...ess Measure key in Measure mode to select Trace Select Manual or in the Utility Measure Advanced preset menu set Trace preset to Manual 2 To position the caliper at the trace start point move the Trackball 3 To fix the start point press Set 4 To trace the maximum values of the desired portion of the spectrum move the Trackball NOTE To edit the trace line move the Trackball 5 To complete the measur...

Page 130: ...tart point in the Doppler spectrum move the Trackball 3 To fix the start point press Set 4 To position the vertical caliper at the end point move the Trackball 5 To complete the measurement press Set The system automatically fixes both calipers and traces the maximum value between the two points The system displays this value in the Results Window NOTE When you set the Auto Trace for Both above an...

Page 131: ... end point move the Trackball 5 To complete the measurement press Set The system displays the two peak end point velocities the time interval and the acceleration in the Results Window Time interval To measure a horizontal time interval 1 Press Measure to select Time interval An active caliper with vertical and horizontal dotted lines displays 2 To position the active caliper at the start point mo...

Page 132: ...rement in M Mode functions the same as distance measurement in B Mode It measures the vertical distance between calipers 1 Press Measure once an active caliper with a vertical and horizontal dotted line displays 2 To position the active caliper at the most anterior point you want to measure move the Trackball 3 To fix the start point press Set The system fixes the first caliper and displays a seco...

Page 133: ...ball 5 To complete the measurement press Set The system displays the time interval between the two calipers in the Results Window Slope Time interval and Velocity To measure time and velocity between two points 1 Press Measure to select Time interval An active caliper with vertical and horizontal dotted lines displays 2 To position the active caliper at the start point move the Trackball 3 To fix ...

Page 134: ... portion of the Utility System System Imaging 2 Press Measure on the control panel the Result window displays at the left bottom of the screen To perform measurement select measurement item from left measurement list or select measurement item from primary menu at the bottom of screen To switch from different mode measurement package press Left right arrow keys on the Alphanumeric keyboard NOTE Th...

Page 135: ...o view a report To view a report select Report on the control panel The system displays the report for the current study Figure 2 33 OB B Mode Report 1 Generic Select to view the generic report 2 Obstetrics Select to view a particular exam report If a report has more data on a second page to view the next page adjust the Page Change control on the System Menu To return to scanning do one of the fo...

Page 136: ... field select Delete Value To exclude the field select Exclude Value The data in the field is not visible and is not included in report calculations To include a value that you previously excluded select Exclude Value To type a comment on a report 1 Select Comments The Comments window opens 2 Type comments about the exam 3 To close the Comments window select other Menu To turn the volume measureme...

Page 137: ... 5759238 100 English Rev 2 Delete All report Values You can delete all report values on a report 1 When the Report is displayed on the monitor press the Clear key Figure 2 34 Delete Warning Message 2 Select OK to delete all Select Cancel to cancel the deletion ...

Page 138: ...le equipment malfunctions that could affect measurement accuracy a quality assurance QA plan should be established for the equipment that includes routine accuracy checks with tissue mimicking phantoms Please be advised that all distance and Doppler related measurements through tissue are dependent upon the propagation velocity of sound within the tissue The propagation velocity usually varies wit...

Page 139: ... 5 Sector Probes Circumference Trace mm Full Screen 10 Linear Probes Convex Probes Sector Probes Ellipse mm Full Screen 5 Linear Probes Convex Probes Sector Probes Area Trace mm2 Full Screen 5 Linear Probes Convex Probes Sector Probes Ellipse mm2 Full Screen 5 Linear Probes Convex Probes Sector Probes Time s Timeline Display 5 M mode AM mode CM mode PWD mode CWD mode Slope mm s Timeline Display 10...

Page 140: ... system WHILE the Versana Essential is NOT powered up If you plug in a device while the Versana Essential is powered on your system may become unusable CAUTION DO NOT place an off line paper printer inside the patient environment This assures compliance to leakage current CAUTION DO NOT place an off line paper printer inside the patient environment within the dotted line area noted by 1 in Figure ...

Page 141: ...ential User Guide 3 1 5759238 100 English Rev 2 Chapter 3 After The Exam Is Over System Presets Data Backup Configuring Connectivity Electronic Documentation Assistance Information and System Care and Maintenance ...

Page 142: ... settings Connectivity Setup Define connection and communication setup including exam dataflow information Measure presets Customize exam studies create measurements set up manual sequencing and create OB Tables Reports Presets Allows you to edit the report template diagnosis codes and report comments Admin presets Perform system administrator activities such as setting up user IDs and logon forma...

Page 143: ...uide 3 3 5759238 100 English Rev 2 System Presets Language Keyboard Setup NOTE You must apply the changes on each setup page before moving to the next page 1 In Utility System General select Regional Options Figure 3 1 Region Option ...

Page 144: ... Versana Essential User Guide 5759238 100 English Rev 2 Language Keyboard Setup continued 2 Under Formats select desired language Figure 3 2 Formats selection 3 Under Location select desired location Figure 3 3 Regional Options ...

Page 145: ...ser Guide 3 5 5759238 100 English Rev 2 Language Keyboard Setup continued 4 Under Administrative select Change system locale Figure 3 4 Administrative 5 Select Apply when below message displays Figure 3 5 Change Regional Options ...

Page 146: ...ssential User Guide 5759238 100 English Rev 2 Language Keyboard Setup continued 6 Select the language under Current system locale then select OK Figure 3 6 Set Language 7 Select Cancel not to restart the system Figure 3 7 Restart Request ...

Page 147: ...r Guide 3 7 5759238 100 English Rev 2 Language Keyboard Setup continued 8 In the Keyboards and Languages tab then select Change keyboards Figure 3 8 Change Keyboard 9 Select Add to add the installed services Figure 3 9 Add Service ...

Page 148: ...age Keyboard Setup continued 10 Select the language using the checkbox before the language and then select OK Or select Preview to review the keyboard layout Figure 3 10 Add Input Language 11 Select the language under Default input language Select OK Figure 3 11 Change the System Language ...

Page 149: ...Essential User Guide 3 9 5759238 100 English Rev 2 Language Keyboard Setup continued 12 Select Close to close the window Figure 3 12 Close Window 13 Select Cancel not to restart the system Figure 3 13 Restart Request ...

Page 150: ... select Save Figure 3 14 Change the System Language 15 The system will indicate to restart the system select OK to continue Figure 3 15 Information Window 16 When the system boots up the system appears in the selected language NOTE To have the settings take effect you MUST restart the system NOTE Press Ctrl Shift to change the input method press Alt Shift to change the input language ...

Page 151: ...the same software version Depending on the system you can use either a CD R DVD R USB Flash Drive or USB Hard Disk for system backup restore For the sake of simplicity we have used the CD R in the following examples NOTE The system ONLY supports CD R DVD R and DOES NOT support CD RW DVD R WARNING GE is not responsible for lost data if the suggested backup procedures are not followed and will not a...

Page 152: ...hive Report Archive User defined configuration Service CAUTION Archived data is managed at the individual sites Performing data backup to any device is recommended CAUTION Make sure to verify the media after writing of data such as EZBackup SaveAs or Export Verifying media requires additional time which varies depending on the amount of data backed up or exported CAUTION Before deleting a patient ...

Page 153: ... backup media by keeping a log and by creating a media filing system For example if you need to back up 500 MB day or 2 5 GB week then you need to back up 5 CDs week or 250CDs year Generally speaking you should back up the system when you have 10 GB of images to back up You should assign the person who is in charge of performing the backups Backups will vary by the volume of your work You need to ...

Page 154: ... first EZBackup wizard screen if the last time you were performing EZBackup you selected Cancel CAUTION If you use EZBackup or EZMove as a true patient archive you must maintain a separate backup of the patient database Patient Archive and Report Archive If for any reason the Local Archive Int HD gets corrupted or the base system software has to be reloaded then the patient archive is the ONLY way...

Page 155: ...ore if EZBackup EZMove encounters an image that is greater than the capacity of the media it skips the oversized image NOTE EZBackup EZMove does not store images to media in sequential order Instead it maximizes the most amount of images per media NOTE If the system locks up during the media auto format process shutdown the system by holding down the power button and reboot the system After the sy...

Page 156: ... volume EZBackup EZMove can take up to 20 minutes or longer depending on the size of the backup Make sure to schedule this at the same time daily when no patients are scheduled 1 Prepare unformatted media or the USB HDD before starting EZBackup EZMove 2 Specify the EZBackup EZMove setup on the Utility System Backup Restore page 3 To start the EZBackup EZMove procedure go to the Patient menu and se...

Page 157: ...exams in the range even if the exam was previously backed up check this option If you uncheck this option the system only backs up exams which have not yet been backed up EZBackup does not back up the exams which were previously backed up once by EZBackup or Export NOTE You can set the range in Utility System Backup Restore Move files older than in days for EZMove NOTE If you update an exam which ...

Page 158: ...ess Next Free Space Total Size tells you the size of the data you have selected to store and the total size of the USB Hard Drive storage media If the storage capacity of the USB HD is insufficient you will see the message Selected Location does not have enough free space NOTE The calculation for the number of backup CD is only an estimate Allow for one additional CD when performing an EZBackup EZ...

Page 159: ... media with not only the volume name indicated on the Insert Media Message but with the name of the Versana Essential system where this backup move procedure was done b Update the EZBackup EZMove log with this information the volume information and the location of the media c After the backup move has been completed file the media Table 3 1 Typical EZBackup EZMove Log Date Scanner ID Name Backup I...

Page 160: ...re 3 19 Check Media If the media is in the drive the window automatically disappears when the checking is completed The EZBackup progress then begins If the media is not in the drive a pop up message appears notifying that there is no media in the drive Press OK Figure 3 20 Insert Disc Error A pop up message appears that provides you with the media label Label the media then insert the media Press...

Page 161: ...ZMove continued 8 The status menu appears When the backup move has been completed press Next Figure 3 21 EZBackup Wizard Page 3 NOTE When if you need to insert the next media a message appears providing you with the media label Label the media then insert the next media and press OK ...

Page 162: ...EZMove continued 9 When the backup is complete the completed wizard page appears Press Finish Figure 3 22 EZBackup EZMove Wizard Page 4 10 Do a patient archive after each EZBackup EZMove We recommend attaching the patient list to the EZBackup EZMove media NOTE Use Import to restore EZBackup images ...

Page 163: ...2 Insert the media volume indicated on the Patient Menu 3 View the exam from the media NOTE You may need to insert a media volume prior to or after the recommended media NOTE If the patient is split over multiple media images on the previous or next media are displayed as triangles NOTE To view the whole patient on the system use Import from as many media as you have for that patient However take ...

Page 164: ...ia into the drive or USB device into a USB port 2 On the Archive screen under dataflow select Local Archive Int HD 3 Go to Utility System Backup Restore 4 In the Backup list Select Patient Archive and Report Archive to backup the patient records Select User Defined Configuration to copy system settings and user presets Select Service to backup service presets NOTE The detailed section of this menu...

Page 165: ...tore Service Settings 3 In the Media field select the appropriate Source device 4 Select Restore The system performs the restore As it proceeds status information is displayed on the Backup Restore screen 5 The Versana Essential restarts automatically when Restore is done CAUTION The restore procedure overwrites the existing database on the local hard drive Make sure to insert the correct media Yo...

Page 166: ...ana Essential systems with identical presets preset synchronization Preset synchronization The procedure for preset synchronization of several scanners is as follow 1 Make a backup of the user defined configurations on a removable media from a fully configured Versana Essential system 2 Restore user defined configurations from the removable media to another Versana Essential system you can restore...

Page 167: ...tings of the selected dataflow and associated services Selecting a dataflow customizes the ultrasound system to work according to the services associated with the selected dataflow 5 Button allows you to assign a pre configured output service or a set of output services to the Print keys on the control panel 6 Removable Media enables formatting DICOM database or blank formatting and DICOM verifica...

Page 168: ...tion software are enabled Software programs CANNOT be loaded onto the Versana Essential e g e mail web browser etc An auto executable file CANNOT be run automatically on the Versana Essential The Versana Essential software includes the latest MS Windows security protection We have worked diligently to develop a combination of the safety measures noted above and the security standards of Windows Em...

Page 169: ...view user documentation on a PC 1 Insert the media into the media drive 2 Open the media drive on your desktop 3 Select and open the item you want to view To close the window press the X in the upper right hand corner of the window NOTE If your PC does not have Adobe Reader a free download is available on the Adobe web site at http www adobe com ...

Page 170: ... seven 7 years from the manufacturing date under the provision of regular maintenance by authorized service personnel Versana Essential probes The expected service life for the Versana Essential probes meets or exceeds five 5 years from the date the probe is placed in service under the provision that the customer follows the care instructions provided on the Probe Care Card that accompanies the Ve...

Page 171: ...quipment for loose or missing hardware Control panel and keyboard for defects Casters for proper locking operation Weekly Maintenance The system requires weekly care and maintenance to function safely and properly Clean the following System Cabinet Monitor Operator control panel Probe holder and Gel holder Footswitch NOTE Frequency of the cleaning is dependent on the environment Failure to perform...

Page 172: ... clean the operator control panel 1 Moisten a soft non abrasive folded cloth with a mild general purpose non abrasive soap and water solution 2 Wipe down operator control panel 3 Use a cotton swab to clean around keys or controls Use a toothpick to remove solids from between keys and controls NOTE When cleaning the operator control panel make sure not to spill or spray any liquid on the controls i...

Page 173: ...ase such as Benzene Methyl Alcohol or Methyl Ethyl Ketone on monitors with the filter anti glare shield Hard rubbing will also damage the filter NOTE When cleaning the screen make sure not to scratch the monitor Footswitch To clean the footswitch 1 Moisten a soft non abrasive folded cloth with a mild general purpose non abrasive soap and water solution 2 Wipe the external surfaces of the unit then...

Page 174: ...er Wipe off any oil or dust from the trackball retainer and the trackball housing using a cleaner or cotton swab 4 Assemble the trackball and retainer then put it into the housing and rotate it clockwise until its notches are set in position CAUTION When cleaning make sure not to spill or spray any liquid into the trackball housing keyboard or system DO NOT use Windex Screen Clean etc as these con...

Page 175: ...d the filters be cleaned every two weeks but the requirements will vary due to your system use Cleaning 1 Power off the system 2 Remove the body left and right cover on both sides Figure 3 24 Remove the body left cover CAUTION Be sure to lock the wheels before cleaning the air filters to avoid injury by any unexpected movement of the system DO NOT operate the unit without the air filters in place ...

Page 176: ...eaning the air filters continued 3 Remove the air filters on body left and right cover Figure 3 25 Remove the Filters 4 Dust the filters with a vacuum cleaner and or wash it with a mild soapy solution If washed rinse and dry the filters before re installation 5 Put back the air filters ...

Page 177: ...ue or a soft cloth dampened with anti static spray on a monthly basis Spray carpets with anti static spray because constant walking on carpets in or near the scanning room may be a source of static electricity Disposal This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately Please contact an authorize...

Page 178: ...ters on page 3 35 System temperature is too high System will shut down 1 Shutdown the system 2 Clean the air filter according to Cleaning the air filters on page 3 35 System voltage fault System will shut down 1 Select OK and reboot the system 2 If the same message appears after reboot shut down the system and turn off the breaker Then turn on the system according to Power On on page 1 36 System E...

Page 179: ...n Contact the distributor GE affiliate or sales representative for approved peripherals For HCATs contact your sales person The following supplies accessories have been verified to be compatible with the system CAUTION DO NOT connect any probes or accessories without approval by GE CAUTION Use only GE approved internal equipment when replacing an internal peripheral The user or the operator should...

Page 180: ...ports two types printer isolation transformers 110V 220V Please use the appropriate type according to the local power supply Table 3 5 Peripherals and Accessories Accessory Units Wireless Adaptor Each Bluetooth Adaptor Each DVD R W Kit with SW Each 1 Pedal Type footswitch Each Footswitch MKF 2 MED USB GP26 Each SONY UP D898DC Printer Each SONY UPD25 Printer Each BW PRINTER UP D898MD Each USB Stick...

Page 181: ...Multi angle disposable needle guide with a reusable plastic bracket E8385NA C2 5 RS Convex Not Available N A N A E8C RS Convex H40402LN Fixed angle disposable needle guide with a reusable plastic bracket E8385MJ Fixed angle reusable with a Stainless Steel Bracket H40412LN 3Sc RS Sector H45041DL Multi angle Disposable needle guide with a reusable plastic bracket H46222LC L5 11 RS Linear Not Availab...

Page 182: ...ngle disposable needle guide with a reusable plastic bracket H40432LC Multi angle disposable needle guide with a reusable plastic bracket H48392LT Fixed angle disposable needle guide with a reusable plastic bracket H48392LL Table 3 6 Probes and Accessories Probe HCAT Biopsy Guide Biopsy Guide HCAT Biopsy Guide HCAT ...

Page 183: ...on Integrated speakers Locking mechanism that provides caster lock 2 cable hooks Front and rear handles Easily removable air filter Wireless adapter option Keyboard Alphanumeric keyboard Interactive back lighting Monitor 15 6 inch Monitor standard 17 3 inch Monitor option High Resolution monitor display Opening angle adjustment Tilt Angle up 45 degrees down 90 degrees rotate angle left 80 degrees ...

Page 184: ...LOGIQ View option Tissue Velocity Imaging TVI Tissue Velocity Doppler TVD with QAnalysis Option System Options Color Flow Mode CFM Power Doppler Imaging PDI CW Doppler CWD Anatomical M Mode AMM Color M Mode CMM Tissue Velocity Imaging TVI Tissue Velocity Doppler TVD LOGIQ View Easy 3D Auto IMT SonoBiometry AFB Scan Coach Scan Assistant OnBoard reporting package DICOM 3 0 Peripheral Options B W ima...

Page 185: ...interests of every ultrasound user to routinely monitor equipment performance The frequency of Quality Assurance evaluations should be based on user s specific needs and clinical practice Periodic monitoring is essential in order to detect the performance changes that occur through normal aging of system components Routine equipment evaluations may also reduce the duration of exams number of repea...

Page 186: ...o the baseline in order to maintain a record of system performance trends Frequency of tests Quality assurance tests are used to determine whether a scanner is providing the same level of performance from day to day The frequency of testing varies with the amount of system usage and modes to be tested It is recommended that the user perform quality assurance tests at least every three months or ev...

Page 187: ...ly positioned to provide information for a variety of tests Doppler phantoms are currently expensive and complicated to deal with on the user level If a problem with any Doppler parameters or measurement is suspected contact a local service representative for evaluation The RMI 403GS phantom is still available Due to the superior penetration and resolution capabilities of GE ultrasound systems the...

Page 188: ...0 English Rev 2 Phantoms continued Figure 3 26 Phantoms 1 Penetration 2 Axial Distance Measurement 3 Functional Resolution 4 Lateral Resolution 5 Lateral Distance Measurement 6 Axial Resolution 7 Contrast Resolution and Gray Scale Photography 8 Gray Scale Plane Targets ...

Page 189: ...itor should be recorded for the permanent record Periodic Checks Periodic checks should be performed in accordance with your facility s quality assurance requirements For the data to be valid periodic checks should mimic the baseline setup parameters The resulting image when scanning the phantom exactly as before should be recorded and compared to the baseline When a matching image is obtained it ...

Page 190: ...lity Assurance Evaluation results should be compared to previously recorded results Performance trends can then be detected Unacceptable performance or diminishing trends should be identified for maintenance or repair before a malfunction or inappropriate diagnosis occurs The user should determine the best method for recording and archiving the baseline and periodic checks In most cases the choice...

Page 191: ...ontrast should be set to the normal viewing of a good gray scale image 2 Check all recording devices for proper duplication of image monitor Ensure that what is seen is what is recorded 3 Annotate non displayed image processing controls 4 Set TGC slide pots to center detent position 5 Place focal zone marker s in area of interest for an optimum image Test Procedures The following are recommended Q...

Page 192: ... depths or fields of view can be tested Procedure To measure axial distance 1 Scan a test phantom with precisely spaced vertical pin targets Adjust all scan controls as necessary for the best image of the pin targets to typical depths for the probe being used 2 Press Freeze to stop image acquisition and perform a standard distance measurement between the pins at different points in the image Recor...

Page 193: ...lds of view can be tested Procedure To measure lateral distance 1 Scan a test phantom with precisely spaced horizontal pin targets Adjust all scan controls as necessary for the best image of the pin targets from side to side 2 Press Freeze to stop image acquisition and perform a standard distance measurement between the pins at different points in the image Record all images for archiving 3 Scan t...

Page 194: ...per interpretation of the ultrasound image Procedure To measure Axial resolution 1 Scan a test phantom with precisely spaced vertical pin targets 2 Adjust all scan controls as necessary for the best image of the pin targets to typical depths for the probe being used 3 Press Freeze to stop image acquisition 4 Perform a standard distance measurement of the pin vertical thickness at different points ...

Page 195: ...a single dot This may lead to improper interpretation of the ultrasound image Procedure To measure lateral resolution 1 Scan a test phantom with precisely spaced horizontal pin targets 2 Adjust all scan controls as necessary for the best image of the pin targets from side to side 3 Press Freeze to stop image acquisition and perform a standard distance measurement of the horizontal thickness of a p...

Page 196: ... Method Scan a phantom to see how echoes begin to fade as depth is increased The maximum depth of penetration is the point at which homogeneous material in the phantom begins to lose brightness Procedure To measure penetration 1 Set the front panel TGC slide pots to their center detent position 2 Gain and acoustic output can be adjusted as necessary since these values are displayed on the monitor ...

Page 197: ...ion of the smallest structure the system is capable of resolving at a given depth Procedure To measure functional resolution 1 Set the front panel TGC slide pots to their center detent position 2 Gain and acoustic output can be adjusted as necessary since these values are displayed on the monitor 3 Scan a test phantom with a vertical row of anechoic cyst targets to typical depths for the probe bei...

Page 198: ...mal surrounding tissue Method A phantom with echogenic targets of different sizes and depths should be used Procedure To measure contrast resolution 1 Set the front panel TGC slide pots to their center detent position Set dynamic range to 54 db 2 Gain and acoustic output can be adjusted as necessary since these values are displayed on the monitor 3 Scan a test phantom with echogenic targets at the...

Page 199: ...he manufacturer s instructions until the hard copy and video display are equal 2 Scan the phantom and it s echogenic contrast targets 3 Make a hard copy photograph of the display and compare it to the image on the video monitor for contrast and weak echo display 4 Document all results for future reference and comparison Contact a Service Engineer if camera cannot duplicate what is on the image mon...

Page 200: ...t Gain Depth Probe Dynamic Range Set up new patient to be the name of the test Annotate the following Any control where its value is NOT displayed Significant phantom information Record Keeping Complete the following 1 Fill out the Ultrasound Quality Assurance Checklist for each probe as scheduled 2 Make a hard copy or archive the image 3 Compare images to baseline images and acceptable values 4 E...

Page 201: ...Serial Number Room Temperature Acoustic Output Gain Focal Zone Gray Map TGC Depth Monitor Setting Peripheral Settings Other Image Processing Control Settings Table 3 11 Part 2 Test Baseline Value Range Tested Value Image Hardcopy Archived Acceptable Yes No Service Called Date Date Resolved Vertical Measurement Accuracy Horizontal Measurement Accuracy Axial Resolution Lateral Resolution Penetration...

Page 202: ...nter TEL 1 800 682 5327 or 1 262 524 5698 In other locations contact your local Applications Sales or Service Representative Service Questions For service in the United States call GE CARES TEL 1 800 437 1171 In other locations contact your local Service Representative Information Requests To request technical product information in the United States call GE TEL 1 800 643 6439 In other locations c...

Page 203: ...40 TEL 3067 8010 FAX 011 3067 8280 CANADA GE Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa WI 53226 TEL 1 800 668 0732 Customer Answer Center TEL 1 262 524 5698 LATIN SOUTH AMERICA GE Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa WI 53226 TEL 1 262 524 5300 Customer Answer Center TEL 1 262 524 5698 MEXICO GE Sistemas Medicos de Mexico S A de C V Rio Lerma 302 1 y ...

Page 204: ...2 229 CHINA GE Asia No 1 Yongchang North Road Beijing Economic Technology Development Area Beijing 100176 China TEL 8610 5806 8888 FAX 8610 6787 1162 INDIA Wipro GE Pvt Ltd No 4 Kadugodi Industrial Area Bangalore 560067 TEL 91 1 800 425 8025 KOREA 8F POBA Gangnam Tower 343 Hakdong ro Gangnam gu Seoul 135 820 Korea TEL 82 2 6201 3114 NEW ZEALAND 8 Tangihua Street Auckland 1010 New Zealand TEL 0800 ...

Page 205: ...2 2222 BELGIUM LUXEMBURG GE Medical Systems Ultrasound Eagle Building Kouterveldstraat 20 1831 DIEGEM TEL 32 2 719 7204 FAX 32 2 719 7205 CZECH REPUBLIC GE Medical Systems Ultrasound Vyskocilova 1422 1a 140 28 Praha DENMARK GE Medical Systems Ultrasound Park Alle 295 2605 Brøndby TEL 45 43 295 400 FAX 45 43 295 399 ESTONIA FINLAND GE Medical Systems Kuortaneenkatu 2 000510 Helsinki P O Box 330 000...

Page 206: ...und Division Akron u 2 Budaors 2040 Hungary TEL 36 23 410 314 FAX 36 23 410 390 IRELAND NORTHERN IRELAND GE Victoria Business Park 9 Westbank Road Belfast BT3 9JL TEL 44 28 90229900 REPUBLIC OF IRELAND GE Unit F4 Centrepoint Business Park Oak Drive Dublin 22 TEL 353 1 4605500 ITALY GE Medical Systems Italia spa Via Galeno 36 20126 Milano TEL 39 02 2600 1111 FAX 39 02 2600 1599 LUXEMBORG See Belgiu...

Page 207: ...olska Sp z o o ul Woloska 9 02 583 Warszawa Poland TEL 48 22 330 83 00 FAX 48 22 330 83 83 PORTUGAL General Electric Portuguesa SA Avenida do Forte n 4 Fraccao F 2795 502 Carnaxide TEL 351 21 425 1309 FAX 351 21 425 1343 RUSSIA GE Krasnopresnenskaya nab 18 bld A 10th floor 123317 Moscow Russia TEL 7 4957 396931 FAX 7 4957 396932 SPAIN GE Espana C Gobelas 35 37 28023 Madrid TEL 34 91 663 2500 FAX 3...

Page 208: ...nbul TEL 90 212 398 07 00 FAX 90 212 284 67 00 UNITED ARAB EMIRATES UAE GE Dubai Internet City Building No 18 P O Box 11549 Dubai U A E TEL 971 4 429 6101 or 4 429 6161 FAX 971 4 429 6201 UNITED KINGDOM GE Medical Systems Ultrasound TEL 44 1707 263570 71 Great North Road FAX 44 1707 260065 Hatfield Hertfordshire AL9 5EN Manufacturer GE Medical Systems China Co Ltd No 19 Changjiang Road WuXi Nation...

Page 209: ...Versana Essential User Guide 4 1 5759238 100 English Rev 2 Chapter 4 Safety Describes the safety and regulatory information pertinent for operating this ultrasound system ...

Page 210: ...qualified personnel are authorized to operate the system Before authorizing anyone to operate the system it should be verified that the person has read and fully understands the operating instructions contained in this manual It is advisable to maintain a list of authorized operators Should the system fail to operate correctly or if the unit does not respond to the commands described in this manua...

Page 211: ...ltrasound system specifically Maintaining an optimum system environment Using this Manual Notes to emphasize or clarify a point DANGER Indicates that a specific hazard is known to exist which through inappropriate conditions or actions will cause Severe or fatal personal injury Substantial property damage WARNING Indicates that a specific hazard is known to exist which through inappropriate condit...

Page 212: ... Describes precautions necessary to prevent the risk of injury through moving or tipping hazard Console accessories or optional storage devices that can fall on patient user or others Collision with persons or objects may result in injury while maneuvering or during system transport Injury to user from moving the console Moving Using brakes Transporting Acoustic Output Hazard Patient injury or tis...

Page 213: ...esult in serious injury The use of the system outside the described conditions or intended use and disregarding safety related information is considered abnormal use The user must be thoroughly familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device Training assistance is available from GE if needed Disregarding information on safet...

Page 214: ...d result in an incorrect diagnosis The ultrasound system is not meant to be long term storage for patient data or images The customers are responsible for the data on the system and a regular backup is highly recommended It is advisable to back up system data prior to any service repairs to the hard drive It is always possible during system failure and repair to lose patient data GE will not be he...

Page 215: ...n measurement errors or failure to detect details within the image The equipment user must become thoroughly familiar with the equipment operation in order to optimize its performance and recognize possible malfunctions Applications training is available through the local GE representative Added confidence in the equipment operation can be gained by establishing a quality assurance program CAUTION...

Page 216: ...ts Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens or other damage that could allow liquid entry Become familiar with the probe s use and care precautions outlined in Probes and Biopsy CAUTION Ultrasound transducers are sensitive instruments which can easily be damaged by rough handling Take extra care not to drop transducers and avoid contact w...

Page 217: ...ting the ESU Where contact cannot be avoided make sure the transducer or ECG electrodes are not located between the ESU active and dispersive electrodes and keep the ESU cables away from the transducer or ECG cables CAUTION Ultrasound can produce harmful effects in tissue and potentially result in patient injury Always minimize exposure time and keep ultrasound levels low when there is no medical ...

Page 218: ...ion There are no user replaceable or serviceable components inside the console Refer all servicing to GE qualified service personnel only Ensure that unauthorized personnel do not tamper with the unit Electrical Hazard To avoid injury Do not remove protective covers No user serviceable parts are inside Refer servicing to qualified service personnel To assure adequate grounding connect the attachme...

Page 219: ... injury or death by electrical shock WARNING To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth Smoke Fire Hazard The system must be supplied from an adequately rated electrical circuit The capacity of the supply circuit must be as specified WARNING Only approved and recommended peripherals and accessories should be used All peripherals an...

Page 220: ... liquids vapors or gases Malfunctions in the unit or sparks generated by fan motors can electrically ignite these substances Operators should be aware of the following points to prevent such explosion hazards If flammable substances are detected in the environment do not plug in or turn on the system If flammable substances are detected after the system has been turned on do not attempt to turn of...

Page 221: ...nstitution as they apply to personnel and equipment CAUTION Contact with natural rubber latex may cause a severe anaphylactic reaction in persons sensitive to the natural latex protein Sensitive users and patients must avoid contact with these items Refer to package labeling to determine latex content and FDA s March 29 1991 Medical Alert on latex products CAUTION To avoid injury or system damage ...

Page 222: ...connectors on the ultrasound unit simultaneously including ultrasound probe connectors DO NOT touch the conducting parts of the USB Ethernet Video Audio cables when connecting equipment to the unit CAUTION To minimize accidental loss of data perform EZBackup and Backup on a regular basis 1 First perform EZBackup to save the images 2 Next perform Backup at Utility System Backup Restore Enable the f...

Page 223: ...the panel To avoid injury or damage make sure nothing is within the range of motion before moving the monitor and monitor arm This includes both objects and people Pay attention to the monitor arm position to avoid hitting it against anyone or anything Before moving the system to another location be sure to lock monitor monitor arm in transport position The monitor screen may have defective pixels...

Page 224: ... health care professionals to identify latex sensitive patients and be prepared to treat allergic reactions promptly Latex is a component of many medical devices including surgical and examination gloves catheters incubation tubes anesthesia masks and dental dams Patient reaction to latex has ranged from contact urticaria to systemic anaphylaxis For more details regarding allergic reaction to late...

Page 225: ...ds Suitable electrical isolation of such external AC outlets may be required in order to meet UL60601 1 and IEC 60601 1 standards for electrical leakage CAUTION External devices can be used only if CE marked and in compliance with related standards EN 60601 1 or EN 60950 Conformance to EN 60601 1 must be verified Accessory equipment connected to the analog and digital interfaces must be certified ...

Page 226: ...correct the problem by one or more of the following measure s reorient or relocate the affected device s increase the separation between the equipment and the affected device power the equipment from a source different from that of the affected device consult the point of purchase or service representative for further suggestions NOTE The manufacturer is not responsible for any interference caused...

Page 227: ...equipment may characteristically cause electromagnetic interference with other equipment either transmitted through air or connecting cables The term EMC Electromagnetic Compatibility indicates the capability of equipment to curb electromagnetic influence from other equipment and at the same time not affect other equipment with similar electromagnetic radiation from itself Proper installation foll...

Page 228: ...quare root of P d 3 5 E1 square root of P d 7 E1 square root of P Where d separation distance in meters P rated power of the transmitter V1 compliance value for conducted RF E1 compliance value for radiated RF If the maximum transmitter power in watts is rated The separation distance in meters should be 5 2 6 2 6 5 2 20 5 2 5 2 10 5 100 12 0 12 0 24 0 WARNING Portable RF communications equipment i...

Page 229: ...observed to verify normal operation If abnormal operation is observed additional measures may be necessary such as re orienting or relocating the ultrasound system or using an RF shielded examination room may be necessary 1 Use either power supply cords provided by GE or ones designated by GE Products equipped with a power source plug should be plugged into the fixed power socket which has the pro...

Page 230: ...in poor EMC performance of the product 2 Notice against User Modification The user should never modify this product User modifications may cause degradation in EMC performance Modification of the product includes changes in a Cables length material wiring etc b System installation layout c System configuration components d Securing system parts cover open close cover screwing 3 Operate the system ...

Page 231: ... compliant The Versana Essential may also be used safely while connected to devices other than those recommended above if the devices and their specifications installation and interconnection with the system conform to the requirements of IEC EN 60601 1 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards i e IEC60950 for da...

Page 232: ...ons for installing an alternate on board device would include 1 The added device s must have appropriate safety standard conformance and CE Marking 2 The added device s must be used for their intended purpose having a compatible interface 3 Signal or mains isolation devices and additional protective earth may be needed to assure compliance with IEC EN 60601 1 Peripheral used in the non patient env...

Page 233: ...other people who may be around the unit to fully comply with the above recommendations Any electrical device can unintentionally emit electromagnetic waves However minimum device separation distances cannot be calculated for such unspecified radiation When the ultrasound unit is used adjacent to or in close proximity to other equipment the user should be attentive to unexpected device behavior whi...

Page 234: ...y for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A This system is suitable for use in all establishments other than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided t...

Page 235: ...ion or interference may occur due to conducted RF noise on the equipment mains power supply or other signal cable Such interference is easily recognized and distinguishable from patient anatomy and physiological waveforms Interference of this type may delay the examination without affecting diagnostic accuracy Additional mains signal RF isolation or filtering may be needed if this type interferenc...

Page 236: ...similar equipment should be used no closer to any part of this system including cables than determined according to the following method Separation distance according to frequency of transmitter m Rated maximum output of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 7 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a m...

Page 237: ...ial performance The essential performance of the ultrasound unit is 1 The ability to display physiological images as input for diagnosis by trained physician 2 The ability to display physiological traces as aid for diagnosis by trained physician 3 The ability to display quantified data as input for diagnosis by trained physician 4 No component failures 5 No changes in programmable parameters 6 No ...

Page 238: ...ronmental Devices for Versana Essential 1 Right side 2 probe holders 1 gel bottle holder 2 Front panel Inside Printer Box 2 or 3 active probe ports 3 Left side 1 USB Port Only for USB memory disk 2 probe holders 4 Rear panel 1 HDMI port 2 USB ports 1 Ethernet port 100MBase T 1 VGA port 1 Composite out port 1 S Video port ...

Page 239: ...ries without approval by GE within the PATIENT ENVIRONMENT See Supplies Accessories on page 3 39 for more information CAUTION DO NOT use unapproved devices If devices are connected without the approval of GE the warranty will be INVALID Any device connected to the Versana Essential must conform to the requirements for IEC or equivalent standards appropriate to devices CAUTION Unsafe operation or m...

Page 240: ... and increments in steps of 0 2 Always be aware of the acoustic output level by observing the Acoustic Output Display In addition become thoroughly familiar with the Acoustic Output Display and equipment controls affecting output Thermal Index Depending on the examination and type of tissue involved the TI parameter will be one of three types Soft Tissue Thermal Index TIS Used when imaging soft ti...

Page 241: ...r than 50 or higher than 150 of the measured value When display MI 0 6 TI 3 6 the absolute error of MI 0 3 the absolute error of TI 1 8 Ispta The Ispta is the Spatial Peak Temporal Average Intensity The absolute maximum regulatory limit of Ispta is 720 mW cm2 as set by the FDA 510 k guidance of September 9 2008 Controls Affecting Acoustic Output The potential for producing mechanical bioeffects MI...

Page 242: ...Although no harmful biological effects have been demonstrated for ultrasound frequencies intensities or exposure times used in examination with the GE system GE recommends using the lowest acoustic output settings which will produce diagnostically acceptable information HINTS Raise the Acoustic Output only after attempting image optimization with controls that have no effect on Acoustic Output suc...

Page 243: ...Standard maintenance must be performed by authorized service personnel for the lifetime of the product 7 years CAUTION Proceed cautiously when crossing door or elevator thresholds Use the handle to push pull the system e g do not use the monitor Failure to do so may cause serious injury or system damage ...

Page 244: ...products will not leak or mutate under normal operating conditions so that the use of such electronic information products will not result in any severe environmental pollution any bodily injury or damage to any assets The unit of the period is Year In order to maintain the declared EFUP the product shall be operated normally according to the instructions and environmental conditions as defined in...

Page 245: ...J T 11364 O Indicates that hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in GB T 26572 X Indicates that hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in GB T 26572 Data listed in the table represents best information available at the time of publication Ap...

Page 246: ...ate Probes Identification and Rating Plate Date of manufacture The date could be a year year and month or year month and day as appropriate See ISO 8601 for date formats Rating Plate Serial Number Rating Plate Catalog Number Rating Plate Type Class Label Used to indicate the degree of safety or protection IP Code IPX8 IPX8 FSU 1000 MKF 2 MED GP26 Indicates the degree of protection provided by the ...

Page 247: ...s or potential equalization conductors is not necessary in most cases and is only recommended for situations involving multiple equipment in a high risk patient environment to provide assurance that all equipment is at the same potential and operates within acceptable leakage current limits An example of a high risk patient would be a special procedure where the patient has an accessible conductiv...

Page 248: ... of such electrical and electronic products will not result in any severe environmental pollution any bodily injury or damage to any assets The unit of the period is Year Probe and Rear Panel China Rating Plate Do not place any objects on the monitor Back of Monitor Do not force the monitor with your hands Back of Monitor There is a pinch point on the monitor Take care to avoid injuring hands or f...

Page 249: ...o nationally recognized product safety standards The Mark bears the name and or logo of the testing laboratory product category safety standard to which conformity is assessed and a control number Rating plate Type CF Defib Proof Applied Part heart in the box with paddle symbol is in accordance with IEC 60878 02 06 ECG Module Do not push the system Back of Monitor Do not connect the DVD RW to the ...

Page 250: ... approval procedures that correspond to the requirements of applicable technical regulations of the Customs Union Rear panel Note Only after Russian regulatory registration is complete this label will be located on the console Mark of conformity with the Technical Regulations This product meets the requirements of the Technical Regulations on medical devices approved by Resolution No 753 of the Ca...

Page 251: ...in uses such as gender determination Rating plate Note For China Korea and India only Every system has a unique marking for identification the Unique Device Identification UDI Label The UDI label consists of a series of alpha numeric characters and barcode which uniquely identify the Versana Essential system as a medical device manufactured by General Electric Scan or enter the UDI information int...

Page 252: ...his equipment to perform outside the published specifications Keep power to these devices turned off when near this equipment 4 The equipment weighs approximately 40 kg 88 lbs To avoid possible injury and equipment damage when transporting from one area of use to another Be sure the pathway is clear Limit movement to a slow careful walk Use two or more persons to move the equipment on inclines or ...

Page 253: ...v 2 Warning Label Locations continued NOTE The warning labels are on the rear of the system The label content may be different for different regions Please refer to the warning labels on the system for the actual content Figure 4 3 Versana Essential Rating Plate Label Location ...

Page 254: ...ion Figure 4 4 Probe label NOTE Non GE probes will also have a UDI symbol and equivalent information 1 GE Logo 2 Probe Model Name 3 UDI Symbol and Data Matrix 4 UDI Human Readable Label Text Global Trade Item Number GTIN 01 Manufacturing Date 11 Serial Number 21 5 Type BF CF Applied Part 6 Caution Consult the Manual 7 WEEE Waste Symbol 8 Chinese RoHS Hazardous Substance Symbol 9 CE Mark and Notifi...

Page 255: ...E The probe box label displayed in this manual is only for illustrational purposes Refer to the actual probe box label for the specific information Figure 4 5 Probe box label UDI Global Trade Item Number GTIN Label and Probe Box Barcode Locations Figure 4 6 Probe Label UDI GTIN and Barcode Locations ...

Page 256: ...fety 4 48 Versana Essential User Guide 5759238 100 English Rev 2 UDI Global Trade Item Number GTIN Label and Probe Box Barcode Locations continued Figure 4 7 Probe Box Label UDI GTIN and Barcode Locations ...

Page 257: ...glish Rev 2 Chapter 5 Probes and Biopsy This chapter consists of the information of each probe and describes some special concerns biopsy kits and accessories as well as basic procedures for attaching a biopsy guide to the different types of probes ...

Page 258: ...with one hand Be lightweight and balanced Have rounded edges and smooth surfaces Stand up to typical wear by cleaning and disinfectant agents contact with approved gel etc Cables have been designed to Connect to system with appropriate cable length Cable handling Take the following precautions with probe cables Keep free from wheels Do not bend the cable acutely Avoid crossing cables between probe...

Page 259: ...v 2 Probe orientation Each probe is provided with an orientation marking This mark is used to identify the end of the probe corresponding to the side of the image having the orientation mark on the display Figure 5 1 Orientation Marking on Probe Example 1 Orientation Mark ...

Page 260: ... Month and year of manufacture Probe designation provided on the probe grip and the top of the connector housing so it is easily read when mounted on the system and is also automatically displayed on the screen when the probe is selected Figure 5 2 Displayed Probe Information Probe Naming Conventions Table 5 1 Probe Naming Convention Type Frequency Connector Type C Convex L Linear S Sector 4 in 4C...

Page 261: ...cable casing and connector for cracks cuts tears and other signs of physical damage 2 Test the functionality of the probe Figure 5 3 Probe parts After each use 1 Inspect the probe s lens cable casing and connector for cracks cuts tears and other signs of physical damage 2 Look for any damage that would allow liquid to enter the probe CAUTION If any damage is found DO NOT use the probe until it has...

Page 262: ...ure that the probe face temperature does not exceed the normal operation temperature range Table 5 2 Probe Environmental Requirements Operational Storage Transport Temperature 10 40 C 50 104 F 5 50 C 23 122 F 5 50 C 23 122 F Humidity 30 80 non condensing 10 90 non condensing 10 90 non condensing Pressure 700 1060hPa 700 1060hPa 700 1060hPa CAUTION Check the room temperature before you use the prob...

Page 263: ...probe adaptors into any liquid DO NOT drop the probes or subject them to other types of mechanical shock or impact Degraded performance or damage such as cracks or chips in the housing may result Prior to each use visually inspect the probe lens and case area for cracks cuts tears and other signs of physical damage DO NOT use a probe which appears to be damaged until you verify functional and safe...

Page 264: ...se patient injury or probe damage Observe depth markings and do not apply excessive force when inserting or manipulating intracavitary probes Inspect probes for sharp edges or rough surfaces that could injure sensitive tissue DO NOT apply excessive force to the probe connector when inserting into the probe port The pin of a probe connector may bend ...

Page 265: ...sheaths please contact your local distributor or the appropriate support resource CAUTION Protective barriers may be required to minimize disease transmission Probe sheaths are available for use with all clinical situations where infection is a concern Use of legally marketed sterile probe sheaths is mandatory for intra cavitary and intra operative procedures Use of legally marketed sterile pyroge...

Page 266: ...to Patient e g Cidex Contact with a sterilant to the patient s skin or mucous membrane may cause an inflammation If this happens refer to the sterilant s instruction manual Sterilant Exposure from Probe Handle Connector to Patient e g Cidex DO NOT allow the sterilant to contact the patient Only immerse the probe to its specified level Ensure that no solution has entered the probe s handle before s...

Page 267: ...evices However ultrasound transducers are complex and expensive devices that must be reused between patients It is very important therefore to minimize the risk of disease transmission by using barriers and through proper processing between patients CAUTION Risk of Infection ALWAYS clean and disinfect the probe between patients to the level appropriate for the type of examination and use FDA clear...

Page 268: ...pe the probe with a dry cloth 3 Soak the probe head in water Scrub the probe as needed using a soft sponge gauze or cloth to remove all visible residue from the probe surface 4 Rinse the probe with enough clean potable water 5 Air dry or dry with a soft cloth 6 After cleaning inspect the probe s lens cable casing and connector Look for any damage that would allow liquid to enter the probe Also ins...

Page 269: ... Versana Essential User Guide 5 13 5759238 100 English Rev 2 Cleaning probes continued Figure 5 4 Probe Immersion Levels Table 5 3 Description of Pictogram for Probe Immersion Levels Pictogram Description Fluid Level ...

Page 270: ... arrowhead is used to indicate electric shock hazards Biohazard Patient user infection due to contaminated equipment Usage Cleaning and care instructions Sheath and glove guidelines Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling Use care when handling and protect from damage when not in use Do not immerse the probe into any liquid beyond ...

Page 271: ...s packed with each probe Please refer to the probe care card for GE approved probe disinfectants CAUTION In order for liquid chemical germicides to be effective all visible residue must be removed during the cleaning process Thoroughly clean the probe as described earlier before attempting disinfection You MUST disconnect the probe from the Versana Essential prior to cleaning disinfecting the prob...

Page 272: ... precautions can result in serious injury and equipment damage Do not immerse the probe into any liquid beyond the level specified for that probe Never immerse the transducer connector or probe adapters into any liquid Avoid mechanical shock or impact to the transducer and do not apply excessive bending or pulling force to the cable Transducer damage can result from contact with inappropriate coup...

Page 273: ...n to cause probe damage Methanol ethanol isopropanol or any other alcohol based product Mineral oil Iodine Lotions Lanolin Aloe Vera Olive Oil Methyl or Ethyl Parabens para hydroxybenzoic acid Dimethylsilicone Polyether glycol based Petroleum WARNING Do not use unrecommended gels lubricants They may damage the probe and void the warranty Please refer to the probe care card for GE approved probe ge...

Page 274: ...other infectious substances When you return a probe or part for service Field Engineer or customer you need to clean and disinfect the probe or part prior to packing and shipping the equipment Ensure that you follow probe cleaning and disinfection instructions provided in the Basic User Manual This ensures that employees in the transportation industry as well as the people who receive the package ...

Page 275: ...ocedures ONLY ultrasound gel that is labeled as sterile is sterile Ensure you always use sterile ultrasound gel for those procedures that require sterile ultrasound gel Once a container of sterile ultrasound gel is opened it is no longer sterile and contamination during subsequent use is possible ...

Page 276: ...vex Array Convex Array probes Linear Array Linear Array probes Sector Phased Array Sector Phased Array probes CAUTION Probes for transvaginal and transrectal applications require special handling Transvaginal transrectal examinations and probe insertions should be performed only by personnel with adequate training Refer to the user documentation enclosed with these probes ...

Page 277: ...ations for Use Probe Application 4C RS C2 5 RS E8C RS 3Sc RS L5 11 RS L6 12 RS Abdomen X X X Obstetrics X X X Gynecology X X X Small Parts X X Vascular Peripheral Vascular X X X X Transcranial X Pediatrics Neonatal X X X X Musculoskeletal X X X X Urology X X X Cardiac X Transvaginal Transrectal X Biopsy X X X X ...

Page 278: ...able or cleared for sale in all markets Please contact your local GE Ultrasound representative to get the latest information Table 5 7 Probe Features Probe Application 4C RS C2 5 RS E8C RS 3Sc RS L5 11 RS L6 12 RS LOGIQ View X X X X X X Easy 3D X X X X X X TVI TVD X Scan Coach Scan Assistant X X X X X X Auto IMT X X AMM X X X Color M Mode X CWD X Sono Biometry X X Biopsy X X X X ...

Page 279: ...y Range MHz Doppler Frequency Range MHz 4C RS 3 10 10 2 0 5 0 2 0 3 6 E8C RS 6 5 20 4 2 10 0 4 2 6 3 3Sc RS 2 75 20 1 7 4 0 1 7 3 3 C2 5 RS 3 5 15 2 0 5 0 2 0 3 6 L6 12 RS 7 75 20 4 0 13 0 4 0 6 0 L5 11 RS 7 5 7 3 7 12 0 3 7 5 6 Table 5 9 Slice Thickness Specification Probe Designation Probe Slice Thickness Specification mm 4C RS 12 0mm E8C RS 13 0mm 3Sc RS 16 0mm C2 5 RS 13 0mm L6 12 RS 15 0mm L5...

Page 280: ...9238 100 English Rev 2 Probe Illustration Convex Probe Linear Probe Table 5 10 Convex Probe Illustration Probe Illustration Probe Illustration 4C RS E8C RS C2 5 RS Table 5 11 Linear Probe Illustration Probe Illustration Probe Illustration L6 12 RS L5 11 RS ...

Page 281: ...Probe Discussion Versana Essential User Guide 5 25 5759238 100 English Rev 2 Sector Probe Table 5 12 Sector Probe Illustration Probe Illustration Probe Illustration 3Sc RS ...

Page 282: ...bject mass during the procedure CAUTION The use of biopsy devices and accessories that have not been evaluated for use with this equipment may not be compatible and could result in injury CAUTION The invasive nature of biopsy procedures requires proper preparation and technique to control infection and disease transmission Equipment must be cleaned as appropriate for the procedure prior to use Fol...

Page 283: ...er cleaning methods and the use of certain cleaning and disinfecting agents can cause damage to the plastic components that will degrade imaging performance or increase the risk of electric shock See Probe Safety on page 5 7 for more information WARNING NEVER reuse the TR5 disposable biopsy guide attachment and Disposable sterile Ultra Pro II Needle guide kits ...

Page 284: ...Guidezone Activate the Biopsy Kit by selecting it from the B Mode The available biopsy options appear when Biopsy Kit is selected There are fixed and adjustable angle biopsy kits and plastic disposable and reusable biopsy guides available with the Versana Essential depending on the probe Select the desired biopsy kit ...

Page 285: ...ts a path of the needle The dots which make up the guidezones is the depth readout where Yellow represent 1 cm increments Red represents 5 cm increments The display should be carefully monitored during a biopsy for any needle deviation from the center line or guidezone Before scanning verify the needle can be visualized within the imaging plane User appropriate needle length to reach target area ...

Page 286: ... Needle size chosen Thinner needles may deflect more Table 5 13 Biopsy Guide Availability Probe Fixed Angle Multi Angle MBX1 cm MBX2 cm MBX3 cm E8C RS TR5 85 Degree 15 3 cm RU 90 Degree 4C RS 4 0 6 0 10 0 3Sc RS 4 2 5 7 8 2 L6 12 RS 1 5 2 5 3 5 DANGER Failure to match the guidezone displayed to the guide may cause the needle to track a path outside the zone It is extremely important that when usin...

Page 287: ... gel sterile gel if necessary and disposable needle barrels The disposable needle barrels are available for a variety of needle sizes The bracket is packaged non sterile and is reusable To avoid possible patient contamination ensure bracket is properly cleaned sterilized or disinfected before each use Disposable components are packaged sterile and are single use only Do not use if integrity of pac...

Page 288: ...tachment area on the probe head Figure 5 6 Attachment Filling Removal a Probe Head b Attachment c Filling Removal Tool 3 Clean then disinfect the probe NOTE Ensure that protective gloves are worn WARNING DO NOT use the needle with the catheter soft tube There is a possibility of breaking the catheter in the body CAUTION Before inserting the needle scan the patient to determine the correct puncture...

Page 289: ... Place an adequate amount of ultrasound gel inside the sheath tip the gel is between the sheath inner surface and the probe aperture NOTE Ensure that only acoustic coupling gel is used for this purpose 3 Place the sheath tip over the probe aperture and then pull the sheath end toward the probe handle 4 Inspect the sheath for nicks cuts or tears Figure 5 7 E8C RS Probe with Sheath a Probe Handle b ...

Page 290: ...ure 5 9 Reusable Biopsy Guide a Fix with a screw 2 Place an adequate amount of ultrasound gel on the gel filled sheath tip s outer surface 3 Ensure the guide is properly seated and secure by pushing forward on the needle insertion end of the guide until the attachment node is firmly in place in it s hole CAUTION Patient injury or repeated biopsies may result The needle placement will not be as int...

Page 291: ...eedle path Figure 5 10 Example 2 Pull up on the knob Figure 5 11 a to freely move the needle guide attachment Align the knob with the selected position of the needle guide attachment Push the knob down Figure 5 11 b into the desired slot to secure the angle position of the needle guide attachment Figure 5 11 Pull up and push down the knob WARNING DO NOT attempt to use the biopsy bracket and needle...

Page 292: ...ntinued 3 Fit a convex of the biopsy bracket a in a concave of the probe b Figure 5 12 Probe Bracket Alignment Hold the side a and tuck down the needle guide side b until it clicks or locks in place Figure 5 13 Probe Multi angle Bracket Alignment 2 4 Place an adequate amount of coupling gel on the face of the probe ...

Page 293: ...le Biopsy Guide Assembly continued 5 Place the proper sanitary sheath tightly over the probe and biopsy bracket Use the rubber bands supplied to hold the sheath in place Figure 5 14 Applying Sanitary Sheath 6 Snap the needle guide onto the biopsy guide bracket Figure 5 15 Snap the needle guide ...

Page 294: ... lock a Make sure the needle guide is firmly attached to the bracket Figure 5 16 Lock the Needle guide 8 Choose the desired gauge size needle barrel Twist it back and forth to remove it from the plastic tree Figure 5 17 Needle Barrel 9 Place the needle barrel into the needle clip with the desired gauge facing the needle clip and snap into place Figure 5 18 Needle Barrel Installation ...

Page 295: ...8 100 English Rev 2 Multi Angle Biopsy Guide Assembly continued Remove the biopsy guide 1 Hold the other side and push out the needle clip attachment side See Figure 5 19 Figure 5 19 Remove the biopsy guide CAUTION Prevent damage to the probe lens with finger nails ...

Page 296: ...tion of the arrow b The needle is released from the assembly c Push the probe and the assembly in the direction of the larger arrow to remove the needle Biopsy Needle Path Verification To verify that the path of the needle is accurately indicated within the guidezone on the system monitor perform the following Properly install the bracket and biopsy guide Scan in a container filled with water 47 C...

Page 297: ...n using multi angle guides ensure that the proper guidezone angle is displayed 3 Scan to locate the target Center the target in the electronic guidezone path NOTE Enabling color flow would allow for visualization of the vascular structure around the area to be biopsied 4 Place the needle in the guide between the needle barrel and needle clip Direct it into the area of interest for specimen retriev...

Page 298: ...ose of these items in accordance with current facility guidelines Clean and disinfect the probe See Probe Cleaning Process on page 5 12 for more information The biopsy bracket can be cleaned and disinfected in a recommended disinfecting agent and reused CAUTION When the biopsy needle guide kit is opened all parts must be discarded after the procedure whether they have been used or not ...

Page 299: ... page 5 31 for more information Sterile gel is applied to the transducer face and a sterile sheath completely covers the transducer and cable which has first undergone a thorough cleaning and high level disinfection The invasive nature of biopsy procedures requires proper preparation and technique to control infection and disease transmission Equipment must be cleaned as appropriate for the proced...

Page 300: ...tion of the probe 2 The scanner surgeon sonographer etc should be sterile and gloved 3 Place an adequate amount of sterile coupling gel on the face of the probe 4 Place the proper sterile sheath over the probe and cord Figure 5 21 Applying Sterile Sheath 5 Depending on the type of procedure use either sterile water or sterile gel on the sheath cover NOTE Follow your institutions guidelines on post...

Page 301: ...leaning the system 3 32 footswitch 3 33 operator controls 3 32 system cabinet 3 32 inspecting the system 3 30 maintenance schedule 3 31 Caution icon defined 4 3 CINE mode activating 2 15 circuit breaker description 1 35 circumference measurements ellipse 2 57 spline 2 59 trace 2 58 2 59 cleaning probes 5 12 Clinical measurement accuracy 2 72 Connectivity configuring 3 27 overview of screens 3 27 p...

Page 302: ... 2 67 time interval and velocity 2 67 tissue depth 2 66 M Mode general measurements 2 66 moving the system 1 24 1 28 during transport 1 30 wheels 1 26 N new patient scanning 1 45 O Operator controls 3 32 P patient data deleting 1 53 patient list entering 1 48 patient safety 4 6 peripherals connector panel 1 13 connector panel illustration 1 14 Phantoms 3 47 Power 1 32 circuit breaker 1 35 connecti...

Page 303: ... 3 precaution levels defined 4 3 probes 5 7 handling precautions 5 11 Scan Assistant Availability 2 34 Definitions 2 35 Description 2 36 Exporting Programs 2 44 Setting Up 2 37 Using 2 42 service requesting 3 62 site requirements before the system arrives 1 9 system electrical configurations 1 9 environmental requirements 1 10 power down 1 38 System cabinet 3 32 T TAMAX and TAMEAN Doppler mode mea...

Page 304: ...Index 4 Versana Essential User Guide 5759238 100 English Rev 2 ...

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