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Revision 0 2278812-100 Technical Publications GE Medical Systems LOGIQ 200 and LOGIQ 200 PRO Quality Assurance Manual Copyright© 2000 by General Electric Company Operating Documentation g

LOGIQ 200 and LOGIQ 200 PRO Quality Assurance Manualfrankshospitalworkshop.com/equipment/documents...LOGIQ a200 and LOGIQ 200 PRO ACR Accredited Quality Assurance Procedure Probe ID

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  • Revision 02278812-100

    TechnicalPublications

    GE Medical Systems

    LOGIQ 200 and LOGIQ 200 PROQuality Assurance Manual

    Copyright© 2000 by General Electric Company

    Operating Documentation

    g

  • GE Medical Systems: Telex: 3797371P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.(Asia, Pacific, Latin America, North America)

    GE Medical Systems—Europe: Telex: 695277283 rue de la Miniére BP3478533 BUC Cedex

    GE Medical Systems

    g

  • LOGIQ α200 or LOGIQ 200 PRO

    Quality Assurance Testing Documents

    TABLE of CONTENTS

    TAB #1 ACR Accreditation Overview 3 pages

    TAB #2 Probe ID List 1 PageQA Testing - 2277615-100 16 Pages

    TAB #3 Probe ID List 1 PageProbe 3 2267008-100 4 PagesProbe 4 2272728-100 4 PagesProbe 5 2272729-100 4 PagesProbe 6 2272730-100 4 PagesProbe 7 2272732-100 4 PagesProbe 8 2272733-100 4 PagesProbe 9 2272735-100 4 Pages

    TAB #4 QA Reference Manual - 2262684-100 30 PagesProbe ID List 1 Page

    TAB #5 System Display Format 2 Pages

    TAB #6 Section 4 - Service Manuals 20 Pages

    TAB #7 Section 2 - Service Manuals 75 Pages

    TAB #8 Filling out the ACR Forms 5 Pages

    TAB #9 ACR, Section G: Quality Control 3 PagesACR, Section H: Equipment Chart 1 Page

    TAB #10 Inspection and Calibration Certificate 1 Page

  • GE ULTRASOUND QUALITY ASSURANCEACR ULTRASOUND ACCREDITATION PROGRAM

    The ACR Ultrasound Accreditation Program evaluates qualifications of personnel, equipment,image quality and quality control measures. It is believed that these are the primary factorsimpacting the quality of patient ultrasound imaging.

    The Ultrasound Accreditation Program is carried out through the mail (paper submission), withrandom on site reviews performed as needed for validation or clarification.

    PROGRAM GOALS

    • Improvement in the quality of ultrasound performance.• Provision of educational information by raising awareness of ultrasound issues.• Recognition of ultrasound facilities which meet program objectives.• Collection of national data about the practice of ultrasound.

    DEFINITION OF AN ULTRASOUND FACILITY

    • Ultrasound section within a hospital• Ultrasound service offered in an outpatient setting, e.g., office, multispecialty clinic, or

    imaging center• Mobile ultrasound service

    A separate application is required for each location of ultrasound practice.

    ULTRASOUND ACCREDITATION PROCESS

    The ultrasound accreditation process consists of three parts which must be completedsuccessfully in order to receive accreditation.

    Application – requests credentials of physicians and sonographer personnel.Quality Control Evaluation – requests information about ultrasound quality control.Clinical Image Evaluation – requests specific types of normal ultrasound exams; plus normal andabnormal exams for vascular accreditation.

    QUALITY CONTROL EVALUATION

    1. A quality assurance (QA) program should be in place for each scanner in the facility.

    The quality assurance program must be directed by a medical physicist or by the supervisingradiologist or physician who may appoint an appropriate designee to oversee the program.There must be program documentation which describes the goals of the quality assuranceprogram and the responsibilities involved.

    The person responsible for the quality assurance program must work with the preventivemaintenance professional. Routine quality control testing must occur regularly; a minimumrequirement is semiannually. The same tests must be performed during each testing period sothat changes can be monitored over time and effective corrective action can be taken. Testingresults, corrective action, and the effects of corrective action must be documented andmaintained on site.

  • GE ULTRASOUND QUALITY ASSURANCEACR ULTRASOUND ACCREDITATION PROGRAM

    QUALITY CONTROL EVALUATION (continued)

    The QA program must evaluate at least the following items in Gray-Scale Imaging Mode.Specific QC data will be collected as part of the Full Application that is submitted in the secondphase of the accreditation process.

    • System sensitivity and/or penetration capability.• Image uniformity.• Photography and other hard copy recording.• Low contrast object detectability (optional).• Assurance of electrical and mechanical safety.

    In addition, it is recommended that users verify vertical and horizontal distance measurementaccuracy when a QA program is initiated for a scanner. It is not required that these factors bereassessed during QC testing.

    These items may be assessed using commercially available phantoms. At the present time,there is no single phantom that is preferred; users should select a phantom from currentcommercially available units.

    2. Test Frequency

    QA tests should be done at least semiannually for each scanner as part of the qualityassurance program for the site. Test results must be documented so that trends in equipmentperformance can be identified and appropriate corrective action taken.

    3. Transducers

    On an ongoing basis, tests should be done using two probes commonly used with anyscanner employing more than one transducer. It is recommended that these be of differentscan formats such as one linear (or curvilinear) array and one sector (mechanical, phased orvector).

    4. Data to be Submitted for Accreditation

    For each scanner, submit the QC Summary (Section G of the Full Application) which showsthe data acquired from one of the semiannual tests. The QC Summary should documentresults from testing the transducer (which includes two probes with different formats). Datashould be taken from testing of the transducer which is used for the most frequently occurringexamination at the site.

    Visit the ACR web site for more details:

    http://www.acr.org/f-standards.html

  • GE ULTRASOUND QUALITY ASSURANCEACR ULTRASOUND ACCREDITATION PROGRAM

    HOW GE ULTRASOUND CAN HELP

    The ACR Quality Control Evaluation and Program is where we can help our customers with GEQuality Assurance Evaluations (PMs).

    New QA procedures are being written and tested to ensure that we incorporate the items that arerequired by the ACR. It may be a slightly new mindset for the Field Engineer as it will require alittle more documentation so that the customer maintains records necessary to determineperformance trends.

    The new QA testing that can be offered by GE Ultrasound will consist of:

    • System QA Procedure – A Job Card style document with checks, tests and space available toattach hard copy images for archival.

    • QA Reference Manual – A detailed explanation of each check and test in the procedure. TheFE can refer to this if necessary.

    • ACR Quality Control, Section G &H – Electronic versions of the official ACR paper submittalforms. We have permission from the ACR to reprint this part of the accreditation application.

    How I envision this to work. All forms are electronic and will be on a CD:

    • FE opens up System QA Procedure on field laptop.• FE performs appropriate checks and tests in the System QA Procedure.• FE makes necessary entries on the electronic form.• FE makes required hard copy images.• At the completion of the System QA Procedure, FE prints out the procedure, attaches the hard

    copy images in the appropriate place on the printout.• While the FE completed the System QA Procedure on the laptop, the ACR Quality Control –

    Section G (and maybe H) forms are filled in automatically. The FE prints out the ACR formsand signs them.

    • The FE gets customer approval and leaves the completed System QA Procedure and ACRforms with the customer, with instructions that Quality Control – Section G & H can be used tosubmit for ACR approval with the remainder of the paper application required by the ACR.

    • Customer should also be reminded that retention of records for performance trends is critical,if not mandatory.

    NOTE: One extra thing we could do (for all or warranty/contract customers) is provide a QCbinder with divider tabs. This would allow the customer to maintain records of preventative andcorrective maintenance for trending and audit purposes.

  • 05/23/00 MAC

    Page 1 of 2

    LOGIQ a200 and LOGIQ 200 PRO

    ACR Accredited Quality Assurance Procedure

    Probe ID List

    Name Model # Type Frequency Scan Format

    CBF H460222CB Gen Purp 3-5 MHz Curved LinearCAE H46022CA Gen Purp 5-7.5 MHz Curved LinearMTZ H46022MT Endo Vag 5-7.5 MHz Curved LinearCZB H45202CZ Superficial 5-7.5 MHz Curved LinearCS H45222CS Gen Purp 3-5 MHz Curved LinearERB H45202ER Endorectal 5-7.5 MHz Curved Linear3Cb H45202WB Gen Purp 3-5 MHz Curved LinearLH H46022LH Superficial 7.5 MHz + LinearLE H46022LE Gen Purp 5-7.5 MHz LinearLI H46022LI Intraoperative 7.5 MHz + LinearLT H46022LT Intraoperative 7.5 MHz + LinearLB H46022LB Gen Purp 3-5 MHz LinearLD H45202LD Intraoperative 3-5 MHz Linear10L H45202LM Gen Purp 5-7.5 MHz LinearSY H46022SY Gen Purp 3-5 MHz Phased ArrayS317 H45202SD Gen Purp 3-5 MHz Phased ArrayATR H4061PR Endorectal 5-7.5 MHZ Curved Linear

  • 05/23/00 MAC

    Page 2 of 2

  • 2277615-100REV 0g GE Medical Systems 1/16

    Purpose: Quality Assurance Testing

    Customer Name:

    Address: System Model:

    System Serial #:

    System ID #: Year of Mfg.:

    System Status: Warranty Contract Billable

    Dispatch #:Purchase Order #:

    System Configuration

    Video Cassette RecorderLine PrinterVideo Page PrinterUrological Therapy GuidanceOther ____________________________________________________________________________

    Field Service Engineer: ____________________________________ Employee #: _______________

    TEST EQUIPMENT

    NAME MANUFACTURER MODEL Atten. SERIAL # CAL DATE

    Leakage Tester

    Multimeter

    Gray Scale Phantom

    Survey Date:

    Refer to the Ultrasound QA ReferenceManual 2262684-100 for details.

    TRANSDUCERS TESTEDThe two transducers used most frequently should be listed as transducer number 1 and 2. Use theseparate documents provided to document the remaining transducers.

    Transducer 1Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Transducer 2Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Configuration Notes:

    US Unit Manufacturer:

    Biopsy GuideSpectral DopplerColor

    Michael A ClawsonNameModel #Type Frequency Scan Format CBFH460222CBGen Purp 3-5 MHz Curved LinearCAEH46022CAGen Purp 5-7.5 MHz Curved LinearMTZ H46022MTEndo Vag 5-7.5 MHz Curved LinearCZB H45202CZSuperficial 5-7.5 MHz Curved LinearCSH45222CSGen Purp 3-5 MHz Curved LinearERBH45202EREndorectal 5-7.5 MHz Curved Linear3CbH45202WBGen Purp 3-5 MHz Curved LinearLHH46022LHSuperficial 7.5 MHz + LinearLEH46022LEGen Purp 5-7.5 LinearLIH46022LIIntraop 7.5 MHz + LinearLTH46022LTIntraop 7.5 MHz + LinearLBH46022LBGen Purp 3-5 MHz LinearLDH45202LDIntraop 3-5 MHz Linear10LH45202LMGen Purp 5-7.5 MHz LinearSYH46022SYGen Purp 3-5 MHz Phased ArrayS317H45202SDGen Purp 3-5 MHz Phased ArrayATRH4061PREndorectal 5-7.5 MHZ Curved Linear

  • 2277615-100REV 0g GE Medical Systems 2/16

    CHASSIS SOURCE LEAKAGE TESTQA Reference Manual Section 3-5. Max allowable is 300 uA.IMPORTANT: Be sure to pause the polarity reverse switch in the OFF position for a minimum of 10seconds before reversing polarity.

    GROUND CONSOLE GROUND CONSOLEPOWER POLARITY SWITCH CHASSIS GND POWER POLARITY SWITCH CHASSIS GNDON NORM Closed ON REV ClosedON NORM Open ON REV OpenOFF NORM Closed OFF REV ClosedOFF NORM Open OFF REV Open

    Chassis Source Leakage Tests Summary PASS FAIL

    Transducer Leakage Current Test Summary: Choose Pass or Fail and Change or No Change

    Transducer 1 PASS FAILCHANGE NO CHANGE

    Transducer 2 PASS FAILCHANGE NO CHANGE

    TRANSDUCER LEAKAGE CURRENT TESTSAll readings in micro-amps. Maximum allowable leakage current is 100 uA for general purpose andendocavitary or 50 uA for surgical probes. QA Reference Manual Section 3-9.

    DALE 600 DALE 600POLARITY GND SW PROBE 1 PROBE 2NORM Closed

    NORM Open

    LINE VOLTAGE TESTSystem OFF: ______________VAC__ System ON: ________________VAC__

    LINE CURRENT TEST (optional)System OFF: ______________Amps_ System ON: ________________Amps_

    OUTLET WIRING TEST QA Reference Manual Section 3-3. If correct, proceed to the next step.

    Correct Wiring Open Ground WireReversed Polarity Open Neutral WireHot & Gnd Reversed Open Hot Wire

    GROUND CONTINUITYQA Reference Manual Section 3-4. Use the Dale 600 Tester. Resistance should be less than 0.2Ohms. If greater than 0.2 Ohms, perform detailed chassis leakage tests and troubleshoot.

    TEST POINT Resistance (ohms) TEST POINT Resistance (ohms)Console _______________ Probe Screw ______________(any side screw)Caster _______________ Foot Switch ________________Monitor _______________ Printer ________________

    VCR ________________

    Ground Continuity Tests PASS FAIL

  • 2277615-100REV 0g GE Medical Systems 3/16

    PHYSICAL INSPECTION/CLEANING

    Cleaned and inspected the console? YES NOCleaned and inspected foot switch? YES NOAll cords and cables intact (no frays, tears or splits)? YES NOAll transducers intact

    (no cracks, dents, scratches or delamination)? YES NOAll transducer connector pins straight and intact? YES NOAll transducer strain reliefs in good condition? YES NOAll transducers cleaned (after each use)? YES NOImage monitors cleaned? YES NOCleaned and inspected all power supplies? YES NOAll fans and/or air filters cleaned? YES NOChecked all cable connectors to ensure they are properly seated? YES NOChecked all plug-in boards to ensure they are properly seated? YES NOAll wheel locks in working condition? YES NOAll wheels fastened securely? Do they rotate easily? YES NOAll "onboard" peripherals fastened securely

    to the ultrasound unit (VCRs, Cameras, Printers, etc....)? YES NOVCR Inspected CleanedPrinter Inspected CleanedCamera Inspected Cleaned

    Cleaned thermal printer print head with cleaner paper? YES NO

    Overall Electrical Safety and Cleanliness:

    CHANGE NO CHANGE

    All safety problems must be rectified before the system can be returned to service or before ACRAccreditation submittal.

    Comments: _____________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

  • 2277615-100REV 0g GE Medical Systems 4/16

    Supply Actual Reading Adjusted To

    +5v Digital

    -5v Digital

    +5v Analog

    -5 v Analog

    +15

    -15

    +12v

    -12v

    HV

    Power Supply Readings Refer to Chapter 4, Section 4-3 of the LOGIQ a200 or LOGIQ 200 PRO ServiceManuals for details on tolerances, checking and adjusting of power supplies.

    Functional Checks Refer to Chapter 4, Section 4-2 of the LOGIQ a200 or LOGIQ 200 PRO Service Manual.

    General B-Mode B/M-Mode M-Mode

    Foot Switch Focus Oper. Focus Oper. Focus Oper.

    Record Key Gain Knob Gain Knob Gain Knob

    Freeze Key TGC Pots TGC Pots TGC Pots

    Printer Setting Dynamic Range Dynamic Range Dynamic Range

    Comments: _____________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    NOTE: Refer to the LOGIQ a200 or LOGIQ 200 PRO User Manual for more information on system operation.

    Reference is 0 voltage for the supply being measured.

    Comments: ____________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

    Power Supplies availabledepend on the type of systemserviced.

    Check only those that apply.

    Mark all other entries N/A.

  • 2277615-100REV 0g GE Medical Systems 5/16

    GRAY SCALE TESTRefer toChapter 2, Section 2-3-2 in the LOGIQ a200 or LOGIQ 200PRO Proprietary manual for details onentering the service software program, tests and control commands.

    Select Monitor Test from the Service Utility Menu

    The gray scale test is not intended to set up the camera, printer or peripherals to the test pattern. Ensurethat the monitor and photography are set up to the customer specifications.

    Look at the gray bar test pattern on the left side of the viewing monitor.

    Count the number of distinct gray bar steps on the viewing monitor. Then count the number of stepsvisualized in the Gray bar on the hard copy image. Circle the number of steps, if any, that are missing onthe hard copy. Circle the number of steps, if any, that are missing on the hard copy.

    Check the one box that applies:

    Number of steps missing on the hard copy: 0 1 2 3 4+

    Has the photography changed since the last QA Test?

    Change No Change (or First Test)

    NOTE: Press to exit the Monitor Test

    SECURE PAGE PRINT OF GRAY SCALE TEST HERE

  • 2277615-100REV 0g GE Medical Systems 6/16

    PERFORMANCE EVALUATION TESTSOVERVIEW

    The following tests should be performed with each probe. Where indicated, a hard copy record shouldbe made and filed in order to assess performance trending during subsequent QA checks.

    Refer to the QA Procedures Reference Manual for details in performing any tests.

    .PHANTOMTemperature __________________________

    * Remember that phantom temperature may demonstrate errors in excess of 10% if you are establishinga baseline or comparing to previous results.

    Probe 1:

    For Probe 1, adjust the system settings to produce the best possible overall image of the phantom.This scan will be used to assess penetration capabilities, image uniformity, measurementaccuracy, axial resolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE 1 SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box toindicate the relative position ofeach TCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

  • 2277615-100REV 0g GE Medical Systems 7/16

    Probe 1 (cont'd):

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distanceof two targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines howwell the system/probe can display two targets above and below each other. The smallest visibledistance of two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualizedis: Less than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 116.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same withthe horizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

  • 2277615-100REV 0g GE Medical Systems 8/16

    Probe 1 (cont'd):

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targetslook but how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. Ifthey are not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    Partial

    Not Seen

    Changed for Worse Y/N

    Overall Probe Low Contrast Detectability:Change No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overall diameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by freezing the image. Press the Measurement key three (3) times to assess the gray scale contrast level.A 3 cm square box appears in the image area.Position the box in the center of the contrast object.Press Set.Record the resulting number as the Object Contrast in the chart above.

    Object Detectability - Check one box according to your evaluation of the object.Changed for Worse Y/N - Enter a Y (yes) or N (no).

    Document any system setting changes if they are different than the original scan on page 6.

    _____________________________________________________________________________

    _____________________________________________________________________________

    _____________________________________________________________________________

    Michael A ClawsonSince this step is currently optional, if your phantom does not have contrast objects, proceed to the next step.

  • 2277615-100REV 0g GE Medical Systems 9/16

    SECURE PAGE PRINT OFPROBE 1 NOISE LEVEL

    SCAN HERE

    Probe 1 (cont'd):

    Noise Level. QA Reference Manual Section 4-2 Step 5. Ensure that room lighting is set to normalscanning conditions. Describe the lighting conditions for repeatability during the next QA check.

    ___________________________________________________________________________________________________________

    Adjust the system settings to produces a clean image.Wipe all the gel from the probe face, and set the probe in its holder. With transmit power at afixed value, adjust the overall gain, until the far field image (beyond 3cm) begins to fill with noise.Reduce the overall gain until the last of those noise “speckles” disappear.

    Note the gain level on film and make a hard copy record of this test.

    Gain: ________________________ Focus : ________________________

    For scan repeatability duringthe next QA check, place acheck mark in a box toindicate the relative position ofeach TCG control for the scan.

  • 2277615-100REV 0g GE Medical Systems 10/16

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualizedis: Less than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 16.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Probe 2:

    For Probe 2, adjust the system settings to produce the best possible overall image of the phantom.This scan will be used to assess penetration capabilities, image uniformity, measurementaccuracy, axial resolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE 2 SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box toindicate the relative position ofeach TCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

  • 2277615-100REV 0g GE Medical Systems 11/16

    Probe 2 (cont'd):

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same withthe horizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distanceof two targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines how wellthe system/probe can display two targets above and below each other. The smallest visible distanceof two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

  • 2277615-100REV 0g GE Medical Systems 12/16

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targetslook but how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. Ifthey are not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    Partial

    Not Seen

    Changed for Worse Y/N

    Overall Probe Low Contrast Detectability:Change No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overalldiameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by freezing the image. Press the Measurement key three (3) times to assess the gray scale contrast level.A 3 cm square box appears in the image area.Position the box in the center of the contrast object.Press Set.Record the resulting number as the Object Contrast in the chart above.

    Object Detectability - Check one box according to your evaluation of the object.Changed for Worse Y/N - Enter a Y (yes) or N (no).

    Document any system setting changes if they are different than the original scan on page 6.

    _____________________________________________________________________________

    _____________________________________________________________________________

    _____________________________________________________________________________

    Probe 2 (cont'd):

    Michael A ClawsonSince this step is currently optional, if your phantom does not have contrast objects, proceed to the next step

  • 2277615-100REV 0g GE Medical Systems 13/16

    SECURE PAGE PRINT OFPROBE 2 NOISE LEVEL

    SCAN HERE

    Probe 2 (cont'd):

    Noise Level. QA Reference Manual Section 4-2 Step 5. Ensure that room lighting is set to normalscanning conditions. Describe the lighting conditions for repeatability during the next QA check.

    ___________________________________________________________________________________________________________

    Adjust the system settings to produces a clean image.Wipe all the gel from the probe face, and set the probe in its holder. With transmit power at afixed value, adjust the overall gain, until the far field image (beyond 3cm) begins to fill with noise.Reduce the overall gain until the last of those noise “speckles” disappear.

    Note the gain level on film and make a hard copy record of this test.

    Gain: ________________________ Focus : ________________________

    For scan repeatability duringthe next QA check, place acheck mark in a box toindicate the relative position ofeach TCG control for the scan.

    Customer Acceptance and Sign-offAssure covers and side panels are aligned and secure.Reconnect any peripherals and interconnections removed during the QA Tests.Return the system to it's original location, if moved.Refer to the QA Reference Manual Section 2-15.Gain Customer acceptance that the system is ready to return to service.

    ______________________________________________ _____________Customer Signature Date

    ______________________________________________ _____________Field Engineer Signature Date

  • 2277615-100REV 0g GE Medical Systems 14/16

    OPTIONAL DATA FOR THE LOGIQ α200 OR LOGIQ 200 PRO

    The remainder of the checks are optional steps that can be accomplished by the field engineer or the customer.While the following do not directly affect image quality, it may be good information to archive in the event thatthe system would need to be restored after a catastrophic system failure.

    PRESETSAll system presets can be saved on a 128 Mbyte MOD through the SETUP>UTILITY Menu.

    Press the SETUP MENU Key. Arrow down to USER UTILITY and press SET.

    In the USER UTILITY Menu, ensure that a MOD has been formatted using Media Initialize.

    Perform thye following procedures:Preset Data BackupOB User Table BackupOB Trend Data Backup.

    Label and date the MOD accordingly and have the customer store it in a safe place.

    Preset data backed up at the request of the customer.

    Customer chose not to back up preset data.

    LOGIQ 200 PRO

  • 2277615-100REV 0g GE Medical Systems 15/16

    LOGIQ α200

    This process is more intensive than a LOGIQ 200 PRO. No device is available the save the presetselectronically. Each screen must be displayed on the monitor and a print taken of that display. The printscan then be stored in a safe place for future reference.

    Ask the customer which menus are important for them to archive in the rare case of a catastropic failure.

    PRESETSTo go directly to the system setup parameters pages, press Make prints of all System Setup Parameter pages.

    Remember: Some pages may require two or more prints due to each applications presets and then foreach probe attached. Use the following items as a check list of what menus were printed:

    General System SetupUser OB Table Sub menu

    Probe Parameter 1 SetupPreset 1

    Probe 1Probe 2

    Preset 2Probe 1Probe 2

    Probe Parameter 2 SetupPreset 1

    Probe 1Probe 2

    Preset 2Probe 1Probe 2

    Image Display and Application SetupPreset 1Preset 2

    Body Pattern SetupPreset 1Preset 2

    Comment SetupPreset 1Preset 2

    Measurement SetupPreset 1

    Report Format Sub menuA/N Assignment Sub menuCardiac Calc Sub menu

    Preset 2Report Format Sub menuA/N Assignment Sub menuCardiac Calc Sub menu

    Patient Entry SetupPreset 1Preset 2

  • 2277615-100REV 0g GE Medical Systems 16/16

    Diagnostics Refer toChapter 2, Section 2-3-2 in the LOGIQ a200 or LOGIQ 200PRO Proprietary manual fordetails on entering the service software program, tests and control commands.

    Caution: If you perform the over all System Test it will run for 21 minutes.

    LOGIQ a200 Pass? LOGIQ 200 PRO Pass?Beamformer Scan TestHV TBFADC Linear/Convex PathDSC/Front End Function Sector PathB-Mode Function BPHVB-Mode X-Y Memory MVP HardwareB-Mode Cine B-Mode FunctionM-Mode Function B-Mode CineMST M-Mode FunctionSystem D-RAM MSTEKeyboard KeyboardPIOP PIOPMonitor MonitorPower Supply Power SupplyROM Version

    Comments: _____________________________________________________________________

    _______________________________________________________________________________

    _______________________________________________________________________________

  • 05/23/00 MAC

    Page 1 of 2

    LOGIQ a200 and LOGIQ 200 PRO

    ACR Accredited Quality Assurance Procedure

    Probe ID List

    Name Model # Type Frequency Scan Format

    CBF H460222CB Gen Purp 3-5 MHz Curved LinearCAE H46022CA Gen Purp 5-7.5 MHz Curved LinearMTZ H46022MT Endo Vag 5-7.5 MHz Curved LinearCZB H45202CZ Superficial 5-7.5 MHz Curved LinearCS H45222CS Gen Purp 3-5 MHz Curved LinearERB H45202ER Endorectal 5-7.5 MHz Curved Linear3Cb H45202WB Gen Purp 3-5 MHz Curved LinearLH H46022LH Superficial 7.5 MHz + LinearLE H46022LE Gen Purp 5-7.5 MHz LinearLI H46022LI Intraoperative 7.5 MHz + LinearLT H46022LT Intraoperative 7.5 MHz + LinearLB H46022LB Gen Purp 3-5 MHz LinearLD H45202LD Intraoperative 3-5 MHz Linear10L H45202LM Gen Purp 5-7.5 MHz LinearSY H46022SY Gen Purp 3-5 MHz Phased ArrayS317 H45202SD Gen Purp 3-5 MHz Phased ArrayATR H4061PR Endorectal 5-7.5 MHZ Curved Linear

  • 05/23/00 MAC

    Page 2 of 2

  • 2267008-100REV 0g GE Medical Systems 1/4

    Probe 3Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Leakage Current Test Summary: Choose Pass or Fail and Change or No Change

    Probe 3 PASS FAILCHANGE NO CHANGE

    PERFORMANCE EVALUATION

    TRANSDUCER LEAKAGE CURRENT TESTSAll readings in micro-amps. Maximum allowable leakage current is 100 uA for general purpose andendocavitary or 50 uA for surgical probes. QA Reference Manual Section 3-9.

    DALE 600 DALE 600POLARITY GND SW PROBE 3NORM Closed

    NORM Open

    For Probe 3, adjust the system settings to produce the best possible overall image of the phantom. Thisscan will be used to assess penetration capabilities, image uniformity, measurement accuracy, axialresolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

    Michael A ClawsonNameModel #Type Frequency Scan Format CBFH460222CBGen Purp 3-5 MHz Curved LinearCAEH46022CAGen Purp 5-7.5 MHz Curved LinearMTZ H46022MTEndo Vag 5-7.5 MHz Curved LinearCZB H45202CZSuperficial 5-7.5 MHz Curved LinearCSH45222CSGen Purp 3-5 MHz Curved LinearERBH45202EREndorectal 5-7.5 MHz Curved Linear3CbH45202WBGen Purp 3-5 MHz Curved LinearLHH46022LHSuperficial 7.5 MHz + LinearLEH46022LEGen Purp 5-7.5 LinearLIH46022LIIntraop 7.5 MHz + LinearLTH46022LTIntraop 7.5 MHz + LinearLBH46022LBGen Purp 3-5 MHz LinearLDH45202LDIntraop 3-5 MHz Linear10LH45202LMGen Purp 5-7.5 MHz LinearSYH46022SYGen Purp 3-5 MHz Phased ArrayS317H45202SDGen Purp 3-5 MHz Phased ArrayATRH4061PREndorectal 5-7.5 MHZ Curved Linear

  • 2267008-100REV 0g GE Medical Systems 2/4

    Probe 3 (cont'd):

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distance oftwo targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines how wellthe system/probe can display two targets above and below each other. The smallest visible distanceof two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualized is:

    Less Than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 16.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same with thehorizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

  • 2267008-100REV 0g GE Medical Systems 3/4

    Probe 3 (cont'd):

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targets lookbut how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. If theyare not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    PartialNot Seen

    Changed for Worse Y/N

    Overall Probe Low Contarst DetectabilityChange No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overalldiameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by Freezing the image. Press the Measurement key three (3) times to assess the gray scale contrast level.A 3 cm square box appears in the image area.Position the box in the center of the contrast object.Press Set.Record the resulting number as the Object Contrast in the chart above.

    Object Detectability - Check one box according to your evaluation of the object.Changed for Worse Y/N - Enter a Y (yes) or N (no).

    Document any system setting changes if they are different than the original scan on page 6.

    _____________________________________________________________________________

    _____________________________________________________________________________

    _____________________________________________________________________________

    Michael A ClawsonSince this step is currently optional, if your phantom does not have contrast objects, proceed to the next step.

  • 2267008-100REV 0g GE Medical Systems 4/4

    SECURE PAGE PRINT OFPROBE NOISE LEVEL

    SCAN HERE

    Probe 3 (cont'd):

    Noise Level. QA Reference Manual Section 4-2 Step 5. Ensure that room lighting is set to normalscanning conditions. Describe the lighting conditions for repeatability during the next QA check.

    ___________________________________________________________________________________________________________

    Adjust the system settings to produces a clean image.Wipe all the gel from the probe face, and set the probe in its holder. With transmit power at a fixedvalue, adjust the overall gain, until the far field image (beyond 3cm) begins to fill with noise. Reducethe overall gain until the last of those noise “speckles” disappear.

    Note the gain level on film and make a hard copy record of this test.

    Gain: ________________________ Focus : ________________________

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

  • 2272728-100REV 0g GE Medical Systems 1/4

    Probe 4Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Leakage Current Test Summary: Choose Pass or Fail and Change or No Change

    Probe 4 PASS FAILCHANGE NO CHANGE

    PERFORMANCE EVALUATION

    TRANSDUCER LEAKAGE CURRENT TESTSAll readings in micro-amps. Maximum allowable leakage current is 100 uA for general purpose andendocavitary or 50 uA for surgical probes. QA Reference Manual Section 3-9.

    DALE 600 DALE 600POLARITY GND SW PROBE 3NORM Closed

    NORM Open

    For Probe 3, adjust the system settings to produce the best possible overall image of the phantom. Thisscan will be used to assess penetration capabilities, image uniformity, measurement accuracy, axialresolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

    Michael A ClawsonNameModel #Type Frequency Scan Format CBFH460222CBGen Purp 3-5 MHz Curved LinearCAEH46022CAGen Purp 5-7.5 MHz Curved LinearMTZ H46022MTEndo Vag 5-7.5 MHz Curved LinearCZB H45202CZSuperficial 5-7.5 MHz Curved LinearCSH45222CSGen Purp 3-5 MHz Curved LinearERBH45202EREndorectal 5-7.5 MHz Curved Linear3CbH45202WBGen Purp 3-5 MHz Curved LinearLHH46022LHSuperficial 7.5 MHz + LinearLEH46022LEGen Purp 5-7.5 LinearLIH46022LIIntraop 7.5 MHz + LinearLTH46022LTIntraop 7.5 MHz + LinearLBH46022LBGen Purp 3-5 MHz LinearLDH45202LDIntraop 3-5 MHz Linear10LH45202LMGen Purp 5-7.5 MHz LinearSYH46022SYGen Purp 3-5 MHz Phased ArrayS317H45202SDGen Purp 3-5 MHz Phased ArrayATRH4061PREndorectal 5-7.5 MHZ Curved Linear

  • 2272728-100REV 0g GE Medical Systems 2/4

    Probe 4 (cont'd):

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distance oftwo targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines how wellthe system/probe can display two targets above and below each other. The smallest visible distanceof two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualized is:

    Less Than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 16.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same with thehorizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

  • 2272728-100REV 0g GE Medical Systems 3/4

    Probe 4 (cont'd):

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targets lookbut how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. If theyare not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    PartialNot Seen

    Changed for Worse Y/N

    Overall Probe Low Contarst DetectabilityChange No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overalldiameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by Freezing the image. Press the Measurement key three (3) times to assess the gray scale contrast level.A 3 cm square box appears in the image area.Position the box in the center of the contrast object.Press Set.Record the resulting number as the Object Contrast in the chart above.

    Object Detectability - Check one box according to your evaluation of the object.Changed for Worse Y/N - Enter a Y (yes) or N (no).

    Document any system setting changes if they are different than the original scan on page 6.

    _____________________________________________________________________________

    _____________________________________________________________________________

    _____________________________________________________________________________

    Michael A ClawsonSince this step is currently optional, if your phantom does not have contrast objects, proceed to the next step.

  • 2272728-100REV 0g GE Medical Systems 4/4

    SECURE PAGE PRINT OFPROBE NOISE LEVEL

    SCAN HERE

    Probe 4 (cont'd):

    Noise Level. QA Reference Manual Section 4-2 Step 5. Ensure that room lighting is set to normalscanning conditions. Describe the lighting conditions for repeatability during the next QA check.

    ___________________________________________________________________________________________________________

    Adjust the system settings to produces a clean image.Wipe all the gel from the probe face, and set the probe in its holder. With transmit power at a fixedvalue, adjust the overall gain, until the far field image (beyond 3cm) begins to fill with noise. Reducethe overall gain until the last of those noise “speckles” disappear.

    Note the gain level on film and make a hard copy record of this test.

    Gain: ________________________ Focus : ________________________

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

  • 2272729-100REV 0g GE Medical Systems 1/4

    Probe 5Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Leakage Current Test Summary: Choose Pass or Fail and Change or No Change

    Probe 5 PASS FAILCHANGE NO CHANGE

    PERFORMANCE EVALUATION

    TRANSDUCER LEAKAGE CURRENT TESTSAll readings in micro-amps. Maximum allowable leakage current is 100 uA for general purpose andendocavitary or 50 uA for surgical probes. QA Reference Manual Section 3-9.

    DALE 600 DALE 600POLARITY GND SW PROBE 3NORM Closed

    NORM Open

    For Probe 3, adjust the system settings to produce the best possible overall image of the phantom. Thisscan will be used to assess penetration capabilities, image uniformity, measurement accuracy, axialresolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

    Michael A ClawsonNameModel #Type Frequency Scan Format CBFH460222CBGen Purp 3-5 MHz Curved LinearCAEH46022CAGen Purp 5-7.5 MHz Curved LinearMTZ H46022MTEndo Vag 5-7.5 MHz Curved LinearCZB H45202CZSuperficial 5-7.5 MHz Curved LinearCSH45222CSGen Purp 3-5 MHz Curved LinearERBH45202EREndorectal 5-7.5 MHz Curved Linear3CbH45202WBGen Purp 3-5 MHz Curved LinearLHH46022LHSuperficial 7.5 MHz + LinearLEH46022LEGen Purp 5-7.5 LinearLIH46022LIIntraop 7.5 MHz + LinearLTH46022LTIntraop 7.5 MHz + LinearLBH46022LBGen Purp 3-5 MHz LinearLDH45202LDIntraop 3-5 MHz Linear10LH45202LMGen Purp 5-7.5 MHz LinearSYH46022SYGen Purp 3-5 MHz Phased ArrayS317H45202SDGen Purp 3-5 MHz Phased ArrayATRH4061PREndorectal 5-7.5 MHZ Curved Linear

  • 2272729-100REV 0g GE Medical Systems 2/4

    Probe 5 (cont'd):

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distance oftwo targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines how wellthe system/probe can display two targets above and below each other. The smallest visible distanceof two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualized is:

    Less Than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 16.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same with thehorizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

  • 2272729-100REV 0g GE Medical Systems 3/4

    Probe 5 (cont'd):

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targets lookbut how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. If theyare not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    PartialNot Seen

    Changed for Worse Y/N

    Overall Probe Low Contarst DetectabilityChange No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overalldiameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by Freezing the image. Press the Measurement key three (3) times to assess the gray scale contrast level.A 3 cm square box appears in the image area.Position the box in the center of the contrast object.Press Set.Record the resulting number as the Object Contrast in the chart above.

    Object Detectability - Check one box according to your evaluation of the object.Changed for Worse Y/N - Enter a Y (yes) or N (no).

    Document any system setting changes if they are different than the original scan on page 6.

    _____________________________________________________________________________

    _____________________________________________________________________________

    _____________________________________________________________________________

    Michael A ClawsonSince this step is currently optional, if your phantom does not have contrast objects, proceed to the next step.

  • 2272728-100REV 0g GE Medical Systems 4/4

    SECURE PAGE PRINT OFPROBE NOISE LEVEL

    SCAN HERE

    Probe 5 (cont'd):

    Noise Level. QA Reference Manual Section 4-2 Step 5. Ensure that room lighting is set to normalscanning conditions. Describe the lighting conditions for repeatability during the next QA check.

    ___________________________________________________________________________________________________________

    Adjust the system settings to produces a clean image.Wipe all the gel from the probe face, and set the probe in its holder. With transmit power at a fixedvalue, adjust the overall gain, until the far field image (beyond 3cm) begins to fill with noise. Reducethe overall gain until the last of those noise “speckles” disappear.

    Note the gain level on film and make a hard copy record of this test.

    Gain: ________________________ Focus : ________________________

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

  • 2272730-100REV 0g GE Medical Systems 1/4

    Probe 6Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Leakage Current Test Summary: Choose Pass or Fail and Change or No Change

    Probe 6 PASS FAILCHANGE NO CHANGE

    PERFORMANCE EVALUATION

    TRANSDUCER LEAKAGE CURRENT TESTSAll readings in micro-amps. Maximum allowable leakage current is 100 uA for general purpose andendocavitary or 50 uA for surgical probes. QA Reference Manual Section 3-9.

    DALE 600 DALE 600POLARITY GND SW PROBE 3NORM Closed

    NORM Open

    For Probe 3, adjust the system settings to produce the best possible overall image of the phantom. Thisscan will be used to assess penetration capabilities, image uniformity, measurement accuracy, axialresolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

    Michael A ClawsonNameModel #Type Frequency Scan Format CBFH460222CBGen Purp 3-5 MHz Curved LinearCAEH46022CAGen Purp 5-7.5 MHz Curved LinearMTZ H46022MTEndo Vag 5-7.5 MHz Curved LinearCZB H45202CZSuperficial 5-7.5 MHz Curved LinearCSH45222CSGen Purp 3-5 MHz Curved LinearERBH45202EREndorectal 5-7.5 MHz Curved Linear3CbH45202WBGen Purp 3-5 MHz Curved LinearLHH46022LHSuperficial 7.5 MHz + LinearLEH46022LEGen Purp 5-7.5 LinearLIH46022LIIntraop 7.5 MHz + LinearLTH46022LTIntraop 7.5 MHz + LinearLBH46022LBGen Purp 3-5 MHz LinearLDH45202LDIntraop 3-5 MHz Linear10LH45202LMGen Purp 5-7.5 MHz LinearSYH46022SYGen Purp 3-5 MHz Phased ArrayS317H45202SDGen Purp 3-5 MHz Phased ArrayATRH4061PREndorectal 5-7.5 MHZ Curved Linear

  • 2272730-100REV 0g GE Medical Systems 2/4

    Probe 6 (cont'd):

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distance oftwo targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines how wellthe system/probe can display two targets above and below each other. The smallest visible distanceof two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualized is:

    Less Than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 16.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same with thehorizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

  • 2272730-100REV 0g GE Medical Systems 3/4

    Probe 6 (cont'd):

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targets lookbut how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. If theyare not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    PartialNot Seen

    Changed for Worse Y/N

    Overall Probe Low Contarst DetectabilityChange No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overalldiameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by Freezing the image. Press the Measurement key three (3) times to assess the gray scale contrast level.A 3 cm square box appears in the image area.Position the box in the center of the contrast object.Press Set.Record the resulting number as the Object Contrast in the chart above.

    Object Detectability - Check one box according to your evaluation of the object.Changed for Worse Y/N - Enter a Y (yes) or N (no).

    Document any system setting changes if they are different than the original scan on page 6.

    _____________________________________________________________________________

    _____________________________________________________________________________

    _____________________________________________________________________________

    Michael A ClawsonSince this step is currently optional, if your phantom does not have contrast objects, proceed to the next step.

  • 2272730-100REV 0g GE Medical Systems 4/4

    SECURE PAGE PRINT OFPROBE NOISE LEVEL

    SCAN HERE

    Probe 6 (cont'd):

    Noise Level. QA Reference Manual Section 4-2 Step 5. Ensure that room lighting is set to normalscanning conditions. Describe the lighting conditions for repeatability during the next QA check.

    ___________________________________________________________________________________________________________

    Adjust the system settings to produces a clean image.Wipe all the gel from the probe face, and set the probe in its holder. With transmit power at a fixedvalue, adjust the overall gain, until the far field image (beyond 3cm) begins to fill with noise. Reducethe overall gain until the last of those noise “speckles” disappear.

    Note the gain level on film and make a hard copy record of this test.

    Gain: ________________________ Focus : ________________________

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

  • 2272732-100REV 0g GE Medical Systems 1/4

    Probe 7Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Leakage Current Test Summary: Choose Pass or Fail and Change or No Change

    Probe 7 PASS FAILCHANGE NO CHANGE

    PERFORMANCE EVALUATION

    TRANSDUCER LEAKAGE CURRENT TESTSAll readings in micro-amps. Maximum allowable leakage current is 100 uA for general purpose andendocavitary or 50 uA for surgical probes. QA Reference Manual Section 3-9.

    DALE 600 DALE 600POLARITY GND SW PROBE 3NORM Closed

    NORM Open

    For Probe 3, adjust the system settings to produce the best possible overall image of the phantom. Thisscan will be used to assess penetration capabilities, image uniformity, measurement accuracy, axialresolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

    Michael A ClawsonNameModel #Type Frequency Scan Format CBFH460222CBGen Purp 3-5 MHz Curved LinearCAEH46022CAGen Purp 5-7.5 MHz Curved LinearMTZ H46022MTEndo Vag 5-7.5 MHz Curved LinearCZB H45202CZSuperficial 5-7.5 MHz Curved LinearCSH45222CSGen Purp 3-5 MHz Curved LinearERBH45202EREndorectal 5-7.5 MHz Curved Linear3CbH45202WBGen Purp 3-5 MHz Curved LinearLHH46022LHSuperficial 7.5 MHz + LinearLEH46022LEGen Purp 5-7.5 LinearLIH46022LIIntraop 7.5 MHz + LinearLTH46022LTIntraop 7.5 MHz + LinearLBH46022LBGen Purp 3-5 MHz LinearLDH45202LDIntraop 3-5 MHz Linear10LH45202LMGen Purp 5-7.5 MHz LinearSYH46022SYGen Purp 3-5 MHz Phased ArrayS317H45202SDGen Purp 3-5 MHz Phased ArrayATRH4061PREndorectal 5-7.5 MHZ Curved Linear

  • 2272732-100REV 0g GE Medical Systems 2/4

    Probe 7 (cont' d):

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distance oftwo targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines how wellthe system/probe can display two targets above and below each other. The smallest visible distanceof two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualized is:

    Less Than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 16.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same with thehorizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

  • 2272732-100REV 0g GE Medical Systems 3/4

    Probe 7 (cont' d):

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targets lookbut how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. If theyare not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    PartialNot Seen

    Changed for Worse Y/N

    Overall Probe Low Contarst DetectabilityChange No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overalldiameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by Freezing the image. Press the Measurement key three (3) times to assess the gray scale contrast level.A 3 cm square box appears in the image area.Position the box in the center of the contrast object.Press Set.Record the resulting number as the Object Contrast in the chart above.

    Object Detectability - Check one box according to your evaluation of the object.Changed for Worse Y/N - Enter a Y (yes) or N (no).

    Document any system setting changes if they are different than the original scan on page 6.

    _____________________________________________________________________________

    _____________________________________________________________________________

    _____________________________________________________________________________

    Michael A ClawsonSince this step is currently optional, if your phantom does not have contrast objects, proceed to the next step.

  • 2272732-100REV 0g GE Medical Systems 4/4

    SECURE PAGE PRINT OFPROBE NOISE LEVEL

    SCAN HERE

    Probe 7 (cont' d):

    Noise Level. QA Reference Manual Section 4-2 Step 5. Ensure that room lighting is set to normalscanning conditions. Describe the lighting conditions for repeatability during the next QA check.

    ___________________________________________________________________________________________________________

    Adjust the system settings to produces a clean image.Wipe all the gel from the probe face, and set the probe in its holder. With transmit power at a fixedvalue, adjust the overall gain, until the far field image (beyond 3cm) begins to fill with noise. Reducethe overall gain until the last of those noise “speckles” disappear.

    Note the gain level on film and make a hard copy record of this test.

    Gain: ________________________ Focus : ________________________

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

  • 2272733-100REV 0g GE Medical Systems 1/4

    Probe 8Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Leakage Current Test Summary: Choose Pass or Fail and Change or No Change

    Probe 8 PASS FAILCHANGE NO CHANGE

    PERFORMANCE EVALUATION

    TRANSDUCER LEAKAGE CURRENT TESTSAll readings in micro-amps. Maximum allowable leakage current is 100 uA for general purpose andendocavitary or 50 uA for surgical probes. QA Reference Manual Section 3-9.

    DALE 600 DALE 600POLARITY GND SW PROBE 3NORM Closed

    NORM Open

    For Probe 3, adjust the system settings to produce the best possible overall image of the phantom. Thisscan will be used to assess penetration capabilities, image uniformity, measurement accuracy, axialresolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

    Michael A ClawsonNameModel #Type Frequency Scan Format CBFH460222CBGen Purp 3-5 MHz Curved LinearCAEH46022CAGen Purp 5-7.5 MHz Curved LinearMTZ H46022MTEndo Vag 5-7.5 MHz Curved LinearCZB H45202CZSuperficial 5-7.5 MHz Curved LinearCSH45222CSGen Purp 3-5 MHz Curved LinearERBH45202EREndorectal 5-7.5 MHz Curved Linear3CbH45202WBGen Purp 3-5 MHz Curved LinearLHH46022LHSuperficial 7.5 MHz + LinearLEH46022LEGen Purp 5-7.5 LinearLIH46022LIIntraop 7.5 MHz + LinearLTH46022LTIntraop 7.5 MHz + LinearLBH46022LBGen Purp 3-5 MHz LinearLDH45202LDIntraop 3-5 MHz Linear10LH45202LMGen Purp 5-7.5 MHz LinearSYH46022SYGen Purp 3-5 MHz Phased ArrayS317H45202SDGen Purp 3-5 MHz Phased ArrayATRH4061PREndorectal 5-7.5 MHZ Curved Linear

  • 2272733-100REV 0g GE Medical Systems 2/4

    Probe 8 (cont' d):

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distance oftwo targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines how wellthe system/probe can display two targets above and below each other. The smallest visible distanceof two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualized is:

    Less Than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 16.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same with thehorizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

  • 2272733-100REV 0g GE Medical Systems 3/4

    Probe 8 (cont' d):

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targets lookbut how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. If theyare not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    PartialNot Seen

    Changed for Worse Y/N

    Overall Probe Low Contarst DetectabilityChange No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overalldiameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by Freezing the image. Press the Measurement key three (3) times to assess the gray scale contrast level.A 3 cm square box appears in the image area.Position the box in the center of the contrast object.Press Set.Record the resulting number as the Object Contrast in the chart above.

    Object Detectability - Check one box according to your evaluation of the object.Changed for Worse Y/N - Enter a Y (yes) or N (no).

    Document any system setting changes if they are different than the original scan on page 6.

    _____________________________________________________________________________

    _____________________________________________________________________________

    _____________________________________________________________________________

    Michael A ClawsonSince this step is currently optional, if your phantom does not have contrast objects, proceed to the next step.

  • 2272733-100REV 0g GE Medical Systems 4/4

    SECURE PAGE PRINT OFPROBE NOISE LEVEL

    SCAN HERE

    Probe 8 (cont' d):

    Noise Level. QA Reference Manual Section 4-2 Step 5. Ensure that room lighting is set to normalscanning conditions. Describe the lighting conditions for repeatability during the next QA check.

    ___________________________________________________________________________________________________________

    Adjust the system settings to produces a clean image.Wipe all the gel from the probe face, and set the probe in its holder. With transmit power at a fixedvalue, adjust the overall gain, until the far field image (beyond 3cm) begins to fill with noise. Reducethe overall gain until the last of those noise “speckles” disappear.

    Note the gain level on film and make a hard copy record of this test.

    Gain: ________________________ Focus : ________________________

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

  • 2272735-100REV 0g GE Medical Systems 1/4

    Probe 9Model: ________________________ Serial Number: ______________________________Type: General Purpose Superficial Intraoperative

    Endorectal Endovaginal Other _____________________Freq: 2-3.5 MHz 3-5 MHz 5-7.5 MHz 7.5 MHz and higherScan Format: Phased Array Linear Array Curved Linear Array

    Mechanical Other _____________________

    Leakage Current Test Summary: Choose Pass or Fail and Change or No Change

    Probe 9 PASS FAILCHANGE NO CHANGE

    PERFORMANCE EVALUATION

    TRANSDUCER LEAKAGE CURRENT TESTSAll readings in micro-amps. Maximum allowable leakage current is 100 uA for general purpose andendocavitary or 50 uA for surgical probes. QA Reference Manual Section 3-9.

    DALE 600 DALE 600POLARITY GND SW PROBE 3NORM Closed

    NORM Open

    For Probe 3, adjust the system settings to produce the best possible overall image of the phantom. Thisscan will be used to assess penetration capabilities, image uniformity, measurement accuracy, axialresolution, lateral resolution and contrast detectability.

    SECURE PAGE PRINT OF PROBE SCAN

    For scan repeatability duringthe next QA check, place acheck mark in a box to indicatethe relative position of eachTCG control for the scan.

    Gain: ________________________ Focus : ________________________

    Dynamic Range: ____________________

    Michael A ClawsonNameModel #Type Frequency Scan Format CBFH460222CBGen Purp 3-5 MHz Curved LinearCAEH46022CAGen Purp 5-7.5 MHz Curved LinearMTZ H46022MTEndo Vag 5-7.5 MHz Curved LinearCZB H45202CZSuperficial 5-7.5 MHz Curved LinearCSH45222CSGen Purp 3-5 MHz Curved LinearERBH45202EREndorectal 5-7.5 MHz Curved Linear3CbH45202WBGen Purp 3-5 MHz Curved LinearLHH46022LHSuperficial 7.5 MHz + LinearLEH46022LEGen Purp 5-7.5 LinearLIH46022LIIntraop 7.5 MHz + LinearLTH46022LTIntraop 7.5 MHz + LinearLBH46022LBGen Purp 3-5 MHz LinearLDH45202LDIntraop 3-5 MHz Linear10LH45202LMGen Purp 5-7.5 MHz LinearSYH46022SYGen Purp 3-5 MHz Phased ArrayS317H45202SDGen Purp 3-5 MHz Phased ArrayATRH4061PREndorectal 5-7.5 MHZ Curved Linear

  • 2272735-100REV 0g GE Medical Systems 2/4

    Probe 9 (cont'd):

    Lateral Resolution. QA Reference Manual Section 4-2 Step 1. LATERAL resolution defineshow well the system/probe can display two targets side by side. The smallest visible distance oftwo targets on the same horizontal plane is the Lateral Resolution.

    Note the Lateral Resolution measurement in mm : ________________________________

    Axial Resolution. QA Reference Manual Section 4-2 Step 2. AXIAL resolution defines how wellthe system/probe can display two targets above and below each other. The smallest visible distanceof two targets on the same vertical plane is the Axial resolution.

    Note the Axial Resolution measurement in mm : ________________________________

    Penetration Capability. QA Reference Manual Section 4-2 Step 4. Use the calipers to measurefrom the skin line to the point furthermost in depth where echoes disappear and record the depthin centimeters. The maximum depth through which the echographic pattern can be visualized is:

    Less Than 3.0

    3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

    8.0 8.5 9.0 9.5 10.0 10.5 11.0 11.5 12.0 12.5

    13.0 13.5 14.0 15.0 16.0 or higher

    Did system penetration change since the previous test?

    Change No Change ( or First Test)

    Image Uniformity. Assess the image for uniformity from near field to far field.

    Change No Change (or First Test)

    With your eye, evaluate the scan for image uniformity against the three indicators below:

    The average brightness at the edge of the scan is the same as the average brightness in themiddle.

    Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no vertical or radially oriented shadows from array element dropout.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    There are no noticeable brightness transitions between focal zones.Agree Disagree, slight non-uniformity Disagree, major non-uniformity

    Measurement Accuracy. QA Reference Manual Section 4-2 Step 3. Use the calipers to measurefrom the vertical pin closest to the skin line to the pin furthermost in depth. Do the same with thehorizontal row of pins.

    Did the distance between the pins measured equal the e-caliper measurement?

    Pass Fail

    Change No Change (or First Test)

  • 2272735-100REV 0g GE Medical Systems 3/4

    Probe 9 (cont'd):

    Contrast Resolution. (OPTIONAL) QA Reference Manual Section 4-2 Step 6 & 7. Evaluatethe phantom contrast targets in the current scan. The point is not how any ONE of the targets lookbut how well defined they are from each other, and from the background material.

    Record the following information for five of the contrast targets, if available in the phantom. If theyare not available, indicate with N/A:

    Object Number 1 2 3 4 5

    Object Depth

    Object Size

    Object Contrast *

    Object DetectabilityComplete

    PartialNot Seen

    Changed for Worse Y/N

    Overall Probe Low Contarst DetectabilityChange No Change (or First Test)

    Notes for contrast resolution:Object Depth - is from the skin line to the center of the object.Object Size - is the overalldiameter of the object (all should be the same)Object Contrast -

    Use the Echo Level function by Freezing the image. Press the M